12 b. This information was originally contained in the ...12 b. This information was originally...
Transcript of 12 b. This information was originally contained in the ...12 b. This information was originally...
12 b
This information was originally contained in the February 13 2009 submittal as
ATTACHMENT - Chron - 1
12 b
This information was originally contained in the February 13 2009 submittal as
ATTACHMENT - Chron - 1
middot Withhold from public disclosure under 10 CFR 2390
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Withhold from public disclosure under 10 CFR 2390
middot Withhold from public disclosure under 10 CFR 2390
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Withhold from public disclosure under 10 CFR 2390
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN-shy S~e Manufacture Inslllil lolSE
lacatton Date Date
-8123107Texas
2ndSE
1214107
3rd5E
212810B
41h5E
81412008 Active Cye =767
DummyCyc 10B7
Servlbullbull Call
S11712008 ~ ActIVe wire conslriction errors
5th5E
9132008 Active eye 234
Dummy eyc 3 332
Service call
91312008 bull Active park switchdrive failure error
6thSE
121212008 Actwe eye = 688
Dummy eyc 900
121212008 - Source stuck out rocovered
121412008
MTSN 51te
Location
~penn
Manufacture Date
Inslllil Date
IslSE 2nd SE
21150S
3rdSE
52210B
Servlce Can
6192008 bull Active wire slippage errols
41hSE
9102008 Active Cye - 662
Dummy Cye = 1408
51hSE
121111200S AcUve Cyc 493
Dummy Cyc = 526
121112008middot Source stuck out recovered
1211212008
SHe Manufacture InstaMTSN
Location Oat Date ltSE
- Cal~ ~Bo7
S~e Manufacture InslllllMTSN
Location Date Oate isiS
~Nebr -5130107
2ndSE
615107
2ndSE
9117107
3rdSE
911107
3rd SE
121707
I I I I I I I I I I I I II I I I
4lhSE
11612008 ActveCyc 103
Dummy Cye bull 106
4thSE
311112008 Activo Cye c 52
Dummy Cyebull 27
51hSE
31712008 Active Cye 73
Dummy Cye bull 55
5th SE
6252008 Ael~o Cyebull 205 Dummy Cyebull 97
61hSE
6121200B Active Cyc = 68
Dummy Cyc 41
51hSE
913200B ActiveCyc 85
Dummy Cye = 43
7thSE
9131200B Activ Cye bull 154
Dummy Cyebull 135
7th SE
121812008 Activ Cye bull 109 Dummy eye 62
Servlc Call
9912008 - Active wire constriction errors
Service Can
16i2009 ~ Active wire constriction errors
BlbSE
121292008 Active Cyc 154
Dummy Cye c 135
1212912008 - Source stuck out recovered
123112008
Withhold from publlc dlsclosure under 10 CFR 2390
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN S~e Manufacture Inslllil
lolSE 2ndSE 3rd5E 41h5E Servl bullbull Call 5th5E Service call 6thSE lacatton Date Date
pound -8123107 81412008
S117 12008 ~ ActIVe wire 9132008 91312008 bull Active park
121212008 121212008 - Source Texas 1214107 2281OB Active Cye = 767
conslriction errors Active eye 234
switchdrive failure error Actrve eye = 688 stuck out rocovered
DummyCyc 10B7 Dummy eyc 3 332 Dummy eyc 900 121412008
MTSN 51te Manufacture Inslllil
IslSE 2nd SE 3rdSE Servlce Can 41hSE 51hSE Location Date Date
~penn 6192008 bull Active wire 9102008 1211112008 1211112008middot Source
211508 512210B slippage errols
Active Cye - 662 AcUve Cyc 493 stuck out recovered Dummy Cye = 1408 Dummy Cyc = 526 1211212008
SHe Manufacture Insta I
MTSN Location Oat Date
ltSE 2ndSE 3rdSE I 4thSE 51hSE 61hSE 7thSE Servlc Call BlbSE I - ~Bo7 111612008 3172006 611212008 91312008 121292008 1212912008 - Source
Cal~ 615107 911107 I ActveCyc 103 Active Cye 73 Active Cyc = 68 Activ Cye bull 154 9912008 - Active wire
Active Cyc 154 stuck out recovered I constriction errors I Dummy Cye bull 106 Dummy Cye bull 55 Dummy Cyc 41 Dummy Cye bull 135 Dummy Cye c 135 123112008
I I I
S~e Manufacture Inslllll
MTSN isiS 2ndSE 3rd SE 4thSE 5th SE 51hSE 7th SE Service Can Location Date Oate I
~Nebr -513007
I 311112008 62512008 91312008 121812008 I 16i2009 ~ Active wire 9117107 1217107 Activo Cye c 52 Acl~o Cye bull 205 ActiveCyc 85 Activ Cye bull 109
constriction errors Dummy Cye bull 27 Dummy Cye bull 97 Dummy Cye = 43 Dummy eye 62
Withhold from publlc dlsclosure under 10 CFR 2390
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
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Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
middot Withhold from public disclosure under 10 CFR 2390
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Withhold from public disclosure under 10 CFR 2390
middot Withhold from public disclosure under 10 CFR 2390
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Withhold from public disclosure under 10 CFR 2390
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN-shy S~e Manufacture Inslllil lolSE
lacatton Date Date
-8123107Texas
2ndSE
1214107
3rd5E
212810B
41h5E
81412008 Active Cye =767
DummyCyc 10B7
Servlbullbull Call
S11712008 ~ ActIVe wire conslriction errors
5th5E
9132008 Active eye 234
Dummy eyc 3 332
Service call
91312008 bull Active park switchdrive failure error
6thSE
121212008 Actwe eye = 688
Dummy eyc 900
121212008 - Source stuck out rocovered
121412008
MTSN 51te
Location
~penn
Manufacture Date
Inslllil Date
IslSE 2nd SE
21150S
3rdSE
52210B
Servlce Can
6192008 bull Active wire slippage errols
41hSE
9102008 Active Cye - 662
Dummy Cye = 1408
51hSE
121111200S AcUve Cyc 493
Dummy Cyc = 526
121112008middot Source stuck out recovered
1211212008
SHe Manufacture InstaMTSN
Location Oat Date ltSE
- Cal~ ~Bo7
S~e Manufacture InslllllMTSN
Location Date Oate isiS
~Nebr -5130107
2ndSE
615107
2ndSE
9117107
3rdSE
911107
3rd SE
121707
I I I I I I I I I I I I II I I I
4lhSE
11612008 ActveCyc 103
Dummy Cye bull 106
4thSE
311112008 Activo Cye c 52
Dummy Cyebull 27
51hSE
31712008 Active Cye 73
Dummy Cye bull 55
5th SE
6252008 Ael~o Cyebull 205 Dummy Cyebull 97
61hSE
6121200B Active Cyc = 68
Dummy Cyc 41
51hSE
913200B ActiveCyc 85
Dummy Cye = 43
7thSE
9131200B Activ Cye bull 154
Dummy Cyebull 135
7th SE
121812008 Activ Cye bull 109 Dummy eye 62
Servlc Call
9912008 - Active wire constriction errors
Service Can
16i2009 ~ Active wire constriction errors
BlbSE
121292008 Active Cyc 154
Dummy Cye c 135
1212912008 - Source stuck out recovered
123112008
Withhold from publlc dlsclosure under 10 CFR 2390
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN S~e Manufacture Inslllil
lolSE 2ndSE 3rd5E 41h5E Servl bullbull Call 5th5E Service call 6thSE lacatton Date Date
pound -8123107 81412008
S117 12008 ~ ActIVe wire 9132008 91312008 bull Active park
121212008 121212008 - Source Texas 1214107 2281OB Active Cye = 767
conslriction errors Active eye 234
switchdrive failure error Actrve eye = 688 stuck out rocovered
DummyCyc 10B7 Dummy eyc 3 332 Dummy eyc 900 121412008
MTSN 51te Manufacture Inslllil
IslSE 2nd SE 3rdSE Servlce Can 41hSE 51hSE Location Date Date
~penn 6192008 bull Active wire 9102008 1211112008 1211112008middot Source
211508 512210B slippage errols
Active Cye - 662 AcUve Cyc 493 stuck out recovered Dummy Cye = 1408 Dummy Cyc = 526 1211212008
SHe Manufacture Insta I
MTSN Location Oat Date
ltSE 2ndSE 3rdSE I 4thSE 51hSE 61hSE 7thSE Servlc Call BlbSE I - ~Bo7 111612008 3172006 611212008 91312008 121292008 1212912008 - Source
Cal~ 615107 911107 I ActveCyc 103 Active Cye 73 Active Cyc = 68 Activ Cye bull 154 9912008 - Active wire
Active Cyc 154 stuck out recovered I constriction errors I Dummy Cye bull 106 Dummy Cye bull 55 Dummy Cyc 41 Dummy Cye bull 135 Dummy Cye c 135 123112008
I I I
S~e Manufacture Inslllll
MTSN isiS 2ndSE 3rd SE 4thSE 5th SE 51hSE 7th SE Service Can Location Date Oate I
~Nebr -513007
I 311112008 62512008 91312008 121812008 I 16i2009 ~ Active wire 9117107 1217107 Activo Cye c 52 Acl~o Cye bull 205 ActiveCyc 85 Activ Cye bull 109
constriction errors Dummy Cye bull 27 Dummy Cye bull 97 Dummy Cye = 43 Dummy eye 62
Withhold from publlc dlsclosure under 10 CFR 2390
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
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0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
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2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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sac LccLltlon
MOI-rlIJ1aclull Dall)
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(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
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1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
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12ISIZ00S 109 J6I20~~AC1Newre
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Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN-shy S~e Manufacture Inslllil lolSE
lacatton Date Date
-8123107Texas
2ndSE
1214107
3rd5E
212810B
41h5E
81412008 Active Cye =767
DummyCyc 10B7
Servlbullbull Call
S11712008 ~ ActIVe wire conslriction errors
5th5E
9132008 Active eye 234
Dummy eyc 3 332
Service call
91312008 bull Active park switchdrive failure error
6thSE
121212008 Actwe eye = 688
Dummy eyc 900
121212008 - Source stuck out rocovered
121412008
MTSN 51te
Location
~penn
Manufacture Date
Inslllil Date
IslSE 2nd SE
21150S
3rdSE
52210B
Servlce Can
6192008 bull Active wire slippage errols
41hSE
9102008 Active Cye - 662
Dummy Cye = 1408
51hSE
121111200S AcUve Cyc 493
Dummy Cyc = 526
121112008middot Source stuck out recovered
1211212008
SHe Manufacture InstaMTSN
Location Oat Date ltSE
- Cal~ ~Bo7
S~e Manufacture InslllllMTSN
Location Date Oate isiS
~Nebr -5130107
2ndSE
615107
2ndSE
9117107
3rdSE
911107
3rd SE
121707
I I I I I I I I I I I I II I I I
4lhSE
11612008 ActveCyc 103
Dummy Cye bull 106
4thSE
311112008 Activo Cye c 52
Dummy Cyebull 27
51hSE
31712008 Active Cye 73
Dummy Cye bull 55
5th SE
6252008 Ael~o Cyebull 205 Dummy Cyebull 97
61hSE
6121200B Active Cyc = 68
Dummy Cyc 41
51hSE
913200B ActiveCyc 85
Dummy Cye = 43
7thSE
9131200B Activ Cye bull 154
Dummy Cyebull 135
7th SE
121812008 Activ Cye bull 109 Dummy eye 62
Servlc Call
9912008 - Active wire constriction errors
Service Can
16i2009 ~ Active wire constriction errors
BlbSE
121292008 Active Cyc 154
Dummy Cye c 135
1212912008 - Source stuck out recovered
123112008
Withhold from publlc dlsclosure under 10 CFR 2390
Withhold from public disclosure under 10 CFR 2390
Chronological Sequence of EVents at Four VS sites of Interest
MTSN S~e Manufacture Inslllil
lolSE 2ndSE 3rd5E 41h5E Servl bullbull Call 5th5E Service call 6thSE lacatton Date Date
pound -8123107 81412008
S117 12008 ~ ActIVe wire 9132008 91312008 bull Active park
121212008 121212008 - Source Texas 1214107 2281OB Active Cye = 767
conslriction errors Active eye 234
switchdrive failure error Actrve eye = 688 stuck out rocovered
DummyCyc 10B7 Dummy eyc 3 332 Dummy eyc 900 121412008
MTSN 51te Manufacture Inslllil
IslSE 2nd SE 3rdSE Servlce Can 41hSE 51hSE Location Date Date
~penn 6192008 bull Active wire 9102008 1211112008 1211112008middot Source
211508 512210B slippage errols
Active Cye - 662 AcUve Cyc 493 stuck out recovered Dummy Cye = 1408 Dummy Cyc = 526 1211212008
SHe Manufacture Insta I
MTSN Location Oat Date
ltSE 2ndSE 3rdSE I 4thSE 51hSE 61hSE 7thSE Servlc Call BlbSE I - ~Bo7 111612008 3172006 611212008 91312008 121292008 1212912008 - Source
Cal~ 615107 911107 I ActveCyc 103 Active Cye 73 Active Cyc = 68 Activ Cye bull 154 9912008 - Active wire
Active Cyc 154 stuck out recovered I constriction errors I Dummy Cye bull 106 Dummy Cye bull 55 Dummy Cyc 41 Dummy Cye bull 135 Dummy Cye c 135 123112008
I I I
S~e Manufacture Inslllll
MTSN isiS 2ndSE 3rd SE 4thSE 5th SE 51hSE 7th SE Service Can Location Date Oate I
~Nebr -513007
I 311112008 62512008 91312008 121812008 I 16i2009 ~ Active wire 9117107 1217107 Activo Cye c 52 Acl~o Cye bull 205 ActiveCyc 85 Activ Cye bull 109
constriction errors Dummy Cye bull 27 Dummy Cye bull 97 Dummy Cye = 43 Dummy eye 62
Withhold from publlc dlsclosure under 10 CFR 2390
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
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4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
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0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
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t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
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55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
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Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
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12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc
Proprietary Filing
Company Confidential
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
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0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc Proprietary Filing - Company Confidential
Varian Medical Systems Inc Proprietary filing
The information in this document in its entirety is company confidential and shall not be released without written consent of Varian Medical Systems Inc
This document is submitted in support of
1 30-day filing in accordance with sect3050 (c)(2) for Event 44774 (VariSource) 2 30-day filing in accordance with sect2121 (d)3) for Event 44774 (VariSource) 3 3D-day filing in accordance with sect305D (c)(2) for Event 44790 (GammaMed)
This document contains Attachments
1) VS 28 Sites - listing the 28 VariSource sites of interest 2) VS All Sites -listing all VariSource sites in the United States
~ 3) Chron-1 - provides a spreadsheet timeline of maintenance for four sites 4) Intertek-1 - excerpts from the Intertek study of the wedge block and debris
5) CTB-1 - Customer Technical Bulleting CTB-VS-640A re VariSource events 6) IT- - Tech Tip providing maintenance instruction to Varian FSEs
1 Information cited in the Part 30 and Part 21 reports
Two tables cited in the reports are provided in this document
The list of VariSource sites under investigation in the United States is included as Attachment VS 28 SITES
The list of all VariSource sites in the United States is included as Attachment VS ALL SITES
2 VariSource EVent Background
Three events occurred with the VariSource HDR unit where the active source wire became jammed internally and caused the active source wire to become stuck outside the tungsten shield All events shared the same event sequence and source recovery sequence
1 A regularly scheduled source exchange is completed
2 The Varian FSE (Field Service Engineer) conducts a PVT (Positional Verification Test) several times to calibrate the extension of the source wire
3 The source fails to retract and is stuck outside the HDR unit
The source jamming has occurred during either the third of fourth PVT
While conducting the PVT the Varian FSE is working from the console and the unit is safely installed in the shielded treatment room
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
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Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
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55
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1212912008 154 ~ 135
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f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
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Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
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1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc - Proprietary Filing Company Confidential
In each case after the source becomes jammed the FSE contacted his senior management and the RSO to consult on the situation A conference call is established and maintained throughout the event until the source is secured in the units tungsten safe In all cases additional commands not available to the site users are sent to the HDR unit however they are not successful and it is decided to enter the room and use the emergency retract handle to park the source in the units tungsten safe All entries are made with timekeeping and while wearing electronic dosimeters
There are slight differences in the source recovery from this point on in each event 2a VariSource ~ Southwest Regional Cancer Center Austin TX - December 21
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
2b VariSourcemiddot Hershey Medical Center- December 112008
3
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
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4
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
r HDR unit compared to GammaMed HDR unit
The VariSource and GammaMed units are distinct from each other and the units were developed from entirely different platforms The afterloaders were designed by different companies and until Varian acquired the product line VariSource and GammaMed were competing afterloaders Varian has made no attempt to harmonize the hardware platform and the distinction between the two units remains
(The rest of this page is intentionally blank)
4
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
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9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
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Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
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Site Location
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Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
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f 6tJbullt-Oil-Actlve I IHfl
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2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc bull Proprietary Filing Company Confidential
Some of the differences between the two afterloaders are stated in the following table
4 Compare and contrast GammaMed and VariSource events
The two events are similar only in the time domain Three VariSource events occurred in December 2008 over a 28-day time period and a trend was evident following the third event The GammaMed event was a single occurrence and has not been repeated
Significantly the materials involved in the source jamming are dissimilar Whereas the debris involved in the VariSource events is a fine black material that is easily broken up and dispersed the material involved in the GammaMed is a gummy black material that has an elastic texture
5
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
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0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
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sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii________________
present in any m
_ -The affected wires and a substantial number of unaffected wires have -shyover the past months in the normal course of business ---- ----------~~
----------------
6
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
5 VariSource - Radiation exposure to personnel during event and recovery
In the VariSource events the estimated exposure to all Varian personnel that were involved in the source recovery is low The cumulative dose equivalent is approximately 407 mrem over the three events spread among 6 individuals No patients or clinical 2ersonnel were involved The highest individual exposure was 260 mrem to the whole ~ody
1t1 the GammaMed event no patients were involved and the cumulative dose to three Varianmiddotpersonnel is estimated to be 73 mrem based on electronic dosimetry
6 VariSource - Recurrence prevention
Tech Tip TT-VS-01247B is the latest revision of the original maintenance instruction that was issued to FSEs (Field Service Engineers) on December 232008 Since the issuance of the Tech TIp there have been no recurrences of the source problems at VariSource user sites The Tech Tip is being incorporated into routine maintenance at all VariSource sites
Infiddition to the Tech Tip Varian is continuing extensive study of the event the ~terials involved components involved and manufacturing techniques both in-house ano at our sub-contractor sites The scope of these studies is described later in this document
7 VariSourcemiddot Threshold of debris needed to jam the wire and breakdown into components
Varian has not measured the mass or volume of the material that has been recovered from the affected units However the amount of debris needed to jam the wire is quite small in the order of mill rams a~m~oiiiuiiintsii _______________ _
present in any m
The affected wires and a substantial number of unaffected wires have -- _ - over the past months in the normal course of business ---- ---------- ~~
----------------
6
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
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0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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sac LccLltlon
MOI-rlIJ1aclull Dall)
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(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential 10 VariSource - Damage to wires and evidence ofpitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
-The internal bore of the wedge block is very small - -~-- Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
15 VariSource - Source contamination during transportation This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
I
14 VariSource shy Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
7
Varian Medical Systems Inc bull Proprietary Filing - Company Confidential
10 VariSource - Damage to wires and evidence of pitting and damage
Source wires do not show pitting and damage from use Affected wires have been measured with a micrometer accurate to O001mm and the thickness of the wire is uniform and is indistinguishable from an unused wire
11 VariSource bull Evidence of galling corrosion pitting in the wedge block
The internal bore of the wedge block is very small - ~ Destructive testing was conducted on a wedge block ~a In a Jammed wire everft Photomicrographic examination did not reveal galling corrosion or pitting
- -- -
12 VariSource bull Wedge block material
The wedge block is made from alum in machining
13 VariSource - Presence of PTFE in the debris
PTFE polytetrafluoroethylene is a synthetic f1uoropolymer and is known as Teflon when produced as a brand name product from DuPont
PTFE is present in some internal tubing in the afterloader and in some external catheters that are used It is present in many applicators that are manufactured by Varian and other suppliers The presence of PTFE is due to the fact that when the source wire enters and exits an applicator or catheter made of or lined with PTFE there will some wearing of the PTFE Those small particles will be carried by the source wire back into the HDR unit and present itself as a white dust
14 VariSource - Need for a lubricant and efficacy
A lubricant per se is not necessary but highly desirable that is present in the system provides the slipperiness that a the source wire to move smoothly through the HDR unit and in and out of the applicators
15 VariSource - Source contamination during transportation
This has been investigated and from the study to date the protectiv~ does not contribute to the jamming problem We plan to look further mto the handling and storage of the monocoil sheaths at our supplier sites
7
I
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullIIIIibullbullllliiibullbullbullbullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
16 VariSource - Tech Tip
Tech Tip TI-VS-01247B was issued as a maintenance instruction on December 23 2008 As of February 12 2008 it has been implemented at 26 sites and will be implemented at all 28 sites of interest by February 13th
bull Validation testing has been completed and is summarized immediately below The Tech Tip is attached as TI-1
17 VariSource - Tech Tip TT-VS-01247B Validation Support
Tech Tip VS-TT-01247B was validated on Varians engineering test afterloader VSEXB in conjunction with ongoing Simulation Wire testing The clearing action directed in the Tech Tip was applied to the afterloader four times in succession prior to the start of a Simulation Wire test A single catheter was used for each Simulation Wire tested and the catheter was replaced with each new Simulation Wire put under test
The afterloader ran a minimum of three times the expected maximum field interval between each Tech Tip application For each of the clearing actions the debris removed was barely visible to the unaided eye The afterloader operated without unexpected errors throughout the test After the 4th clearing action application and the testing of the Simulation Wire that followed the Validation Support was concluded Since that time the afterloader has run an additional 20000 extensions without unexpected error
Validation Support Conclusion - After repeated application of Step 25 of Tech Tip TTshyVS-01247B the afterloader continued to operate normally No unexpected outcomes were seen
18 VariSource - Customer Technical Bulletin CTB-VS-640A Distribution
CTB-VS-640A entitled Potential for a source wire path constriction inside the VariSource trade HDR afterloader was distributed starting on February 5 2008 and is being tracked to all recipients in the United States The CTB is attached as CTB-1
19 VariSource - Maintenance and Event Timeline with added cycle data after 4th source exchange and analysis
The retrospective analysis does show errors that may be considered as precursor events This is especially true with the benefit of hindsight and a better understanding of what occurred in each of the events This spreadsheet is attached as Attachment Chron-1
20 VariSource - Feasibility Study of bullbullbull Ii bullbullbull ii bullbull iIIIII bullbullbull
Varian is investigating the developme re
8
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
21 VariSource - Retract Error Retrospective Analysis
9
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
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MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
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t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin Dmiddot 51 furing ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc - Proprietary Filingmiddot Company Confidential
The reports marked as Customer Issue or Applicator issue are as a result of either a difficult applicator with tight bends or the customer having bends in the Transfer guide tubes In these circumstances the errors would have been experienced as the wire is extending
bull Customer Issue - 7 Reports bull Applicator Issue - 4 Reports
--~ -------------- 22 VariSource-
A regularly scheduled audit was conducted conformances were registered by the auditing
non-
conducted in January 2008 following t~middot -nlrllnQlt=gt observed and audited records a~
at the sOUrce manufacturin D 51 ~uring ms were reviewed
Quality records Materiel storage and handling Source builds were observed Past build histories Controlling drawings and procedures
All processes and procedures were in keeping with quality commitments and no activities were noted that contributed to the source wire jamming concern
]0
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
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55
fSIb2000 ActPo-eCYC
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DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
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Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
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-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
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1st Sf f 7hSE srvlltcn
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I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit ofbullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc Proprietary Filing - Company Confidential
23 VariSource - Audit of bullbullbullbullbullbullbullbull The manufacturer of th~s audited in October 2007 The scope of the audit was the Quality Parameters stated in ISO-13485 ISO-9001 and 21 CFR 820 This includes Quality Management Requirements Document Control Purchasing Control Production Control Training and Competence Corrective and Preventive Actions and internal audits No item of non-compliance were identified
24 VariSourcemiddot dummy wire use and load pattern
All FSEs use the same protocol for loading a VariSource dummy wire
25 VariSourcemiddot 10mm measurement of recovered wires
A source wire involved in one of the events was measured every 10mm along its length using a calibrated micrometer There was no evidence of degradation
Investigation
Measurement of recovered wire tails from VS448 amp VS447 using a calibrated Micrometer Two measurements were taken at 90 degrees every 10mm along the length of the two recovered wire tails - (length 258m amp 216m)
(The rest of this page is intentionally blank)
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds (Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
Varian Medical Systems Inc - Proprietary Filing - Company Confidential
26 VariSource dust
Intertek MSG in Wilton United Kingdom studied t~nd debris in January 2009 Intertek is accredited by the United Kingdom~it~ervice and holds Certificate no 0967
Excerpts from the study are in Attachment INTERTEK 1
27 VariSource - Role of room ventilation as possible contamination source
Varian investigated if room ventilation may have played a part in causing a foreign material to enter the HDR unit and act or assist in the material collecting in the wedge block
The Intertek report addresses the issue of the possibility of room ventilation being a possible source of contamination See page 2 of Attachment INTERTEK-1
Investigation
Samples of black material were analysis by a United Kingdom Accreditation Service accredited test house (Intertek MSG) using stereomicroscopy polarized light microscopy and a Hitachi S2700 SEMEDX In addition a crystalline melting point technique (not in the scope of UKAS accreditation) was used to analysis the samples Reference Report from Intertek MSG MICW0728
Conclusion
There is no evidence of contaminates It is therefore concluded ~ product of the PTFE used in a number of the tors and th~
The stainless steel and aluminum storage and guidance track
There is no evidence of external contamination therefore the possibility of room ventilating being a possible source of contamination is remote
28 VariSource and GammaMed - FSE Training Records Review and Summary
All FSEs training records are current and complete
All Facility Service Engineers have a prior background of working with technical machinery either through the Armed Forces or private industry Each newly hired FSE receives at least one week of classroom hands-on instruction learning the operation of the HDR unit its components and service requirements and techniques This one-week of didactic training is repeated for both the VariSource and GammaMed units
Following the didactic training the new hire will spend several months working side-byshyside with another experienced FSE During this time he or she is never allowed to work alone or unsupervised Depending on how the new hire is progressing the OJT portion may last between three and seven months During the OJT period the new hire is evaluated by several other FSEs A written examination is given that must be successfully passed after the new hire is considered competent
11
(
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis ofmaterials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc - Proprietary Filing Company Confidential
After the written test is successfully passed the senior FSEs round table the new hires progress and determine if he or she should be certified to work alone in the field Only after there is agreement that the FSE is competent to work alone is certification granted
29 GammaMed __
United Kingdom provides un au was completed by two Varian
Quality Engineers in February 2007 with a scope to review
bull Control and qualification of the new clean room bull Review of vendor quality controls bull Review calibration records
The results of the audit showed that the program was had a few minor deficiencies but the recommendation was made tha~rk approval should be renewed
An audi--as not conducted in 2008 due to a change in work scope invoIVin~nufacturers The next audit is tentatively scheduled for May 2009
-approved by Lloyds Register Quality Assurance to Quality ~s Standards ISO 9001 2000 and ISO 134852003 and is issued
certificate
Ongoing tasks and expected completion date
30 VariSource - Analysis of materials used near and around the source wire
Varian continues to conduct qualitative and quantitative analyses on the debris and other materials that are used in the HDR unit The following materials are being analyzed and will be compared to the debris that has been recovered from the units involved in the three events
rw r ii ill F + superlubereg - a viscous lubricant UsLd on a bearing in the retract assembly bull Transfer guide tube - a catheter used to connect an applicator to the HDR unit
31 VariSource - Analysis of debris
Extended analyses of the debris are being conducted This is not a simple matter since the mass and volume of the material is on the order of just a few milligrams The tests have to be selected and coordinated so that the material is not destroyed The tests and results analysis is expected to be completed by March 27 2009
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis ofapplicator Usage at affected sites
This task is ongoing with an expected completion date of March 27 2009
35 GammaMed and VariSource - Comparison ofevents
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
Varian Medical Systems Inc Proprietary Filing - Company Confidential
32 VariSource - Clinical housekeeping fluids used at affected sites
Varian Technical Support will be contacting the three VariSource sites that experienced the jammed source wire as well as the site that had the precursor event That action has not been completed and the expected by March 27 2009
33 GammaMed - Analysis of material recovered from McLaren Regional Medical Center
The stickyelastic material recovered from the GammaMed unit at McLaren Regional Medical Center is being analyzed both internally and by an outside consultant The result from that analysis is expected by March 27 2009
34 GammaMed and VariSource - Analysis of applicator Usage at affected sites
This task is ongoing with an expected completion date of March 272009
35 GammaMed and VariSource - Comparison of events
A comparison of the events experienced by the two afterloader models will be a task undertaken after the investigation is completed and conclUSions are developed
36 Lessons learned
Lessons learned will be a task undertaken after the investigation is completed and conclusions are developed
(The rest of this page is intentionally blank)
14
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
-~J
ATTACHMENT
Chron-1
VariSource Event and Maintenance Timeline
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW
Sitcc LCJtM
Maflqf1tturlllOlC
II11itall Date 1st Si
20a SE 3rd S[
i 14th SE SeNice C~U 5th Sf ScnlfcCI Cait 6th SE
VSH t -71 t
b420[J8 ACllcshy ffil
0 2068 Ictllfe w(r~
9J3f~OOU 23oi
VJlttuOii ~Actfie Pl(H~ichlCftVe failure
12tu200e Atl~ Cre oo~
Zi2i2JOt~ bull Sou~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU lZI4()OIS
I I t I
M1 SN
Site Location
Maftufacturu Oa~Q
Install Datu 1st 5E 2nd SE 3td Sf
t t S~rv~cl Call 4th Sf ~th SE
ponn _ 1150( $1l2iOtJ +-ft
f 6tJbullt-Oil-Actlve I IHfl
9f102000 662
121112009 ArUWcCyc4~j3
2ft 1120011 ~ SOOf() stuck Ol1t re-eaver(ld
t sJPPagu enofS 1409 DUfImIj CfC =~ l26 12122006shy
I I I I
VfSN
sac LccLltlon
MOI-rlIJ1aclull Dall)
InstallDa1~ 1stSr ImJSE 3rdSE
(I 41hSE 5th Sf 61nSE 7thSE SOMcoCaU 8thSE
C~f _
i~l07 wt1ft~r J I
1I6i2oo3 10~ 10i
31120lt8 773
55
fSIb2000 ActPo-eCYC
)wn01V Cc lt41
i~l2000 A tWc AdveCyc 00154 1Jl9i200~ c wwe
DtIIlHlly etc 135 (OOstrittI(Ht eno(l
1212912008 154 ~ 135
1212lf1oo6middot 8laquos~tlkotitfeCQre-d
1213112008
I I I I
hUSH
Silo lQcatiQ1
ManifnCUHCDate
Instart Oati 1st 1St 2nd SE rd St
f t 4th 5pound 5th Sf 601 SE 7th SE SI)Mc~ Call
i4~lt ~
__ rl~fj ~
l~F7 ~
t~H)1
mJ2(ID8 r -~~~7
612 ~OOI 11lZOOB -f -4~
12ISIZ00S 109 J6I20~~AC1Newre
-2 con~tricttone-rfJrt
Chronological Sequence of Events at Four VS sites of Interest
lgtlTSW Sitcc Maflqf1tturlll II11itall
1st Si 20d Sf lId S[ i ScnlfcClCait 6lh Sf LCJtN1 OlC Date I
41SE SeNiceC~U 5th SI
I b420[J8 9J3f~OOU VJlttuOii ~ ActfliC Pl( 12Ju200e Zi2i2JOt~ bull Sou~ I 0 12068 bull Ictllgte w(r~
VSHt 71 7 I ACllc- Nil ~ 2gt H~ichlCftVe failure Atl~ Cre oo~ stutk O(t nrovcred
Dllr)my ~ 1(7 COH$ficoon errors n error O~V eyc gOU 12i4iCOij
I I I I I
MT$N Site Maftufacturu Install
1t SF I Location Oa~Q Datu
2nd SE 3dSf I S~rv~cl Call 4lll Sf ~lh SE
I 9f102000 121112009 2ft 1120011 ~ SOOf() ponn - 1150( $1l2iOtJ
I 6tJ2tiOil - Relive IHI B62 AcUWc eye 4~j3 stuck Ol1t re-eaver(ld I sJPPagu enofS I 1409 Dutmnj CfC =~ l26 1212120Q~
I I I I
VfSN sac MOI-rlIJ1aclull Install
1st Sf 2na SE I 5th Sf 7th SE SOMcoCaU 8th SE
LccLltlon Dall) Da1~ d SE I 4th SE SnSE
I vHSi200a 3111206 fSIb2000 i~l2000 1212912008 1212il006middot SQliite - I 9l9i200B AC~ wire
C~f i~l07 wt1ft~r I 1 O~ 773 AeCyt Adve eye 00 154 154 s~tlk Otit feCQre-d
I 10i 55 )wn01V Cc lt41 DtIIlHlly etc 135 (OOstrittIltHt eno(l 13 213112006
I I I I
MfSN Silo ManifncUHc Instart
1st Sf f 7hSE srvlltcn
lQcatiQ1 Dte Oati 2nd SE rd St I 4th SE 5th SE 6 se
I 11112008 6i2~ooa OIlZOOS 121S1200S - I 116l20~ ~ Active wre i -4~ - ~vfn ~l~ fie7 ~11i()1 I ~( f) lOS
I ~ if jU ~B2 con~trictton erfJrt
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
ATTACHMENT
INTERTEK 1
Analysis of wedge block and debris
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UKAS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating ofa clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
Excerpts from the Intertek study on the wedge block and debris
Results Interpretations and Opinions
The work under review was carried out in the electron microscopy building using the techniques of industrial forensic science In this case sterel1microscopy polarised light microscopy and SEM EDX (Hitachi S2700) were utilised On one occasion a crystalline melting point was obtained and this is not included within the scope of UK AS accreditation
-fhe above image illustrates a cross section of H vanilla or unused reference block The intcmal surfaces arc clean and frcc from black deposits Vc noted a thin coating of a clear transparent material on the surfilce and this is thought to be tiom the chemilal preshytreatment This surface coating inside the bore is brittle and glassy
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
The clinical deposit was removed from the package and found to be very homogeneous All the particles were very similar and there was little evidence of any other extraneous contamination such as fibres mineral particles and general office dust The above image is very characteristic of all the particles in the package
2
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
MIC 728 Clinical Deposit VS448
At higher magnifications the cllfved morphology of the particles is visible and this appears to be material that has been attached to the bore - where the wire has been rubbing on the upper surface in the particle above
3
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
In thin section the particle is comprised of a soft transparent continuous phase which is impregnated with opaque black debris The particle size of this debris can be detennined with reference to the attached scale bar (10 microns)
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Clinical Oeposit V8448
R11400
Using a refractive index liquid of 1 AOO the soft transparent continuous phase reveals itself as having a low refractive index (in common with fluoropolymcrs for instance)
5
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial shyprobably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
Using polarised light microscopy the continuous phase exhibits a low birefringence in this section - again a common feature of tluoropolymers A hot stake microscopy experimt11t (Non UKAS) reveals that the melting point oft11is birefringence is very high (in excess of 300 degrees) This is further evidence of a high melting point polymer phase that binds the black opaque particles together
What follows is a sequence of SEM EOX spectra that gives a fingerprint of the inorganic material comprising the particles illustrated above Characteristically the particles contain Fluorine (probably the Fluoropolymer matrix) Titaniw11 and Nickel are also detected and this appears to be due to fine particles entrained in the continuolls phase We postulate tha~ and that the black debris in the light micrographs arc rcprese~vhich is likely to be wear debris Traces oflron were noted in many of the pmticles examined and on searching individual particles we noted small particles of Iron Chrome I Nickel containing mateIial -probably stainless steel Occasionally we noted small Sulphur and Silicon peaks
We therefore postulated that the clinical deposit was a soft fhloropolymer that has acted as a binding agent for wear debris fro~and other parts of the machine
6
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
7 7
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
9 9
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
The black and vvhite images above arc high resolution FESEM images and characterise the clinical deposit well
The soft transparent continuous phase is prone to fibrillation - it is basically a sticky material that defonns under shear similar to PTFE The particles visible in this continuous phase are the wear debris identified as largely being Nitinol in the previous EDX spectra
What follows is poundl similar investigation into the non clinical deposit as supplied to us The similarities to the clinical deposit are striking
10
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
MICW 728 Non Clinical Deposit
11
MICW 728 Non Clinical Deposit
11
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
From the above work we conclude that the clinical and non clinical deposits are to all intents and purposes the same
What follows is an attempt to realise a causal1ink between these deposits and the blocks as supplied to us The same methodology being utilised as was detailed above The only difference being that the blocks were photographed before manual dissection of the intemal deposit took place
J3
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
14 14
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J5
The VS 447 block can be seen to be particularly clean In this case we examined the entry point of the block and retrieved the deposit illustrated below
MICW 128 VS447 wedge block entry end
J 5
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
MICW 728 VS447 wedge block ~
16
MICW 728 VS447 wedge block ~
16
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this are detected and this is characteristic of the clinical deposit
In conclusion
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17
In my opinion the wire has been handled and this has compromised the surface somewhat This is characterised by the presence of Sodium Sulphur Chlorine and Potassium which are often observed in association with fingerprints and handling debris
Quite apart from this of the clinical deposit
In conclusion
are detected and this is characteristic
The deposits observed through out this study have many similarities The internal bore of the blocks is compromised with a black deposit that this very similar to the clinical deposit both in terms of chemistry and morphology
17