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Technical Scrutiny

By: Nicholas Alexander Guerrero

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Table of Contents

Title page.....................................................Page 1Table of Contents.......................................Page 2Dedicated to................................................Page 3 Foreward......................................................Page 4Introduction................................................Page 7The History..................................................Page 11Whats the Problem?...................................Page 16Whose Job is it?...........................................Page 24Conclusion...................................................Page 28 Bibliography.................................................Page 30

Dedicated To...

James Manke3

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Foreword

I first became interested in the subject of robotic surgery, when my

friends father came home one day from work and I had asked him what he

did. He began to explain to me the opportunities, and advantages of robotic

surgery, and I was extremely intrigued. I was also a little skeptical. So I began

to scour the world for the contrary, however, the same numbers kept coming

back. It would seem that the technology was there, and it worked. I also soon

discovered, that the company responsible for this technology also had a dis-

tinct advantage. Intuitive Surgical, is the sole manufacturer and distributer of

the Da Vinci Surgical Robot. Through a number of contacts I also found that

Intuitive was increasingly on the defensive. As the technology becomes more

widespread, so did the apparent opposition. Yet, as far as the numbers, the

accounts, and the technology was concerned there really wasn’t a lot of reason

for that.

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Intuitive’s Patent listings

This shows the locations and cities where Da Vinci systems are located, and operated around the world. Specifically, in Japan and Korea.

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Introduction Intuitive Surgery, a growing, thriving innovative company based in Silicon valley, which develops, and sells the sole machine that performs robotic surgery approved by the FDA, the Da Vinci Robot. Recently, the company and the robot have been under the scrutiny of concerned patients, the media, and the FDA; however, both the company and the system have shown repeated performance of safety, quality, and ease. The question here isn’t whether the technology is safe, but what is there to be afraid of, and what could be contributing to the fear? The system is similar to that of laparoscopic surgery, Da Vinci is designed to perform with minimal exposure, and risk of infection or injury to the patient. Intuitive had corrected any of the robots flaws as soon as they could identify them. Yet, as flaw-less as the system seems to have performed; there are still many lawsuits coming out against the company.

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Intuitive Surgical’s Da Vinci robotic design is

the leading component of minimally invasive

surgical procedures. Being a form of laparo-

scopic surgery, it uses small incisions to insert a small camera, and up

to for surgical arms into the patient. This leads to less time in the hospital,

faster recovery times, and less chance of infec-

tion. These advantages are exactly what has pro-pelled Intuitive, and as a result, Da Vinci into the

field. The benefits of the procedure can be seen as a definite step up from traditional endoscopic, or “open” surgery, because of this, hospitals have been willing to invest in Da Vinci, putting in

up to $2.6 million dollars to remain in the cutting edge. Being the only company in production, Intuitive and it’s products Adding to the cost, surgeons must be properly trained in the equip-

ment. This being critical, as Ryan, Director of Sales and Marketing of Intuitive put it, “It’s like if you work in construction, and you can hand a worker a hammer. Whether they’ve seen a ham-mer or know how to use one is a different story.” (Ryan Shaw) Ryan went on to talk about how

Intuitive maintains a large sales and engineering staff, assigned to the training of the hospital staff, and the maintenance of the robot itself.

This shows the locations of Da Vinci systems, in the U.S. and Europe.

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The History

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In the later models, the adition of a fourth arm and high definition camera greatly enhanced the robots functionality.

The Da Vinci’s instruments are hardly bigger than a penny, which makes for smaller incisions, and less time devoted to recovery.

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Intuitive surgery, was created only because of their Da Vinci product. In 1995, the company was founded after the technology was purchased for the private sector, after the military abandoned their original goals for the research; the goal being, to provide a practical means of applying field surgery from sur-geons based in the US or other areas; however, do to a time delay, that becomes increasingly problematic as distance is increased, the project was naturally not completed. The project was started in the 1980’s DARPA (Defense Advanced Research Programs Agency) provided funding towards multiple institutions in the hope of eventually developing robotic surgeons for the battlefield. This among some of the other projects were flawed, due to the unpredictability of the battlefield, and signal delay from consoles to machines, these made ro-botic surgery on the battlefield all but impractical. However, the funding from DARPA provided the foundation needed to begin Intuitive Surgical and the Da Vinci system. In 1999, Intuitive began Marketing the first Da Vinci system, and in 2000, the system was cleared by the FDA for certain types of surgery. The first product, focused on giving the surgeons a unique perspective as opposed to other laparoscopic surgeries, with 3D viewing of the operation, through its 3D cameras. In 2006, the Da Vinci S system offered High definition vision for the surgeon, the addition of a 4th arm, and offered a more streamlined, or sim-pler design to simplify use. Allow for the more easy integration of the system into the operating room. The first two being significant to the surgeons ability to view the operation and execute the procedure as quickly as possible.

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The system that is being used by Intuitive , and surgeons across the globe, today

is the Da Vinci Si. The Davinci Si was marketed in 2009, along with upgrades to the

quality of the video, surgeon controls, and ergonomics, the Da Vinci Si has the unique

ability to allow for two control consoles, and as a result, two surgeons. This is a signifi-

cant feature that it allows for a multitude of scenarios all of which are beneficial to the

patient and future patients. Two consoles allow for a new surgeon to watch, observe,

and possibly aide a more experienced surgeon, which significantly reduces the learn-

ing curve, putting more experienced surgeons qualified in Da Vinci aiding the less

experienced ones, which shows a reduction in complications in surgery. Also allowing

for more experienced surgeons to quickly pass on advice or advanced surgical tech-

niques via the consoles communication. These advances have allowed for exceptional

quality of procedures and performance by those surgeons properly trained in the sys-

tem. The Da Vinci system at this time requires only 4 small incisions into the body

in order to insert the robotic arms and the 3D optic camera.The robots arms can be

outfitted with a variety instruments, specific to the needs of that specific surgery. The

addition of another control console also increases the chances of experienced surgeons

being present during the procedure.

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Whats the problem?

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The past couple of months have seen Intuitive Surgical, come under fire from a few recent ar-ticles published by Bloomberg, “The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines... The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training.” (Bloomberg Site) This has happened because, as Da Vinci surgeries increase in numbers and fre-

quency, so have that of the number of surgeries that developed ‘compli-cations’. Leading to greater specula-tion about the surgical procedure itself. This is all because the patients and surgeons have become increas-ingly timid. As with most innova-tions, nobody wants a bad invest-ment, and even less people want to be caught in the snare if something does come out to be wrong. How-ever, the system has had a long track history already, and that the system is just constantly being improved upon, and its merits have already spoken for themselves.Even so, the sudden loss of confidence has hurt Intuitive temporarily, because of the need of an FDA regulated investiga-tion. However what this means isn’t necessarily a negative on the com-pany or the system.18

The FDA’s job is to investigate, “The FDA investigates a product, that they have

previously approved, if they feel something might be wrong or if they feel there is rea-

son to investigate.” (Ryan) possible defects, or problems with a particular product or

system. In this case, to determine if a product is safe for patient use. However, the FDA

is not even required to publish anything they find during their investigation.

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When asked about it Ryan says, “We’ve always focused our efforts on the patient first...” referring to how Intuitive goes about receiving and implementing feedback. There are numerous failsafes in the system, and thousands of constant system checks going on every second. All to ensure the machine is working at it’s top performance, and ensuring a safe and speedy procedure; although no conclusive evidence exists, an article written by Daniel M. Herron, MD, in association with SAGES and MIRA, have a little to say on the subject, “...complications have been shown to have a signifi-cant impact on the cost of care. It is generally felt that the use of robotics shortens the learning curve for acquiring complex minimally surgical skills. At present, there are no studies suggesting that robotic procedures performed by experienced robotic sur-geons have different complication rates either better or worse than other comparable techniques...” Looking at the history thus far, though, has shown that the Da Vinci system has a promising future at the very least. Showing a high success rate to a rela-tively low, number of cases that developed significant complications, and most of these were on the error of the surgeon or by complications developed by the patient.

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Still the system maintains a strong advantage over traditional Laparoscopic surgery, Mr. Manke, Director of Videography at Intuitive, is frequently sent out to film, and record, surgery using the Da Vinci system and to create, training videos, presentations, advertisements and other forms of media. When asked about the advantages over traditional surgery, he said: “There are a lot of advantages to robotic surgery. The main pillars to our technology is that it is far less inva-sive than open procedures. Meaning that there is a few smaller incisions rather than larger ones and the reasons thats better is because larger incisions have to cut through muscle and its much more painful rather than small instruments that go through the muscle fibers. Patients heal faster and typically they go home in a day or two after the procedure. Its virtually bloodless because the instruments are performing microsurgery and the ability of the surgeon to control the bleeding with the instruments is much more advanced...” that being said, the system also has it’s limita-tions as was noted, again by Mr.Manke “Right now the surgical system is only designed to work on soft tissue. Because the instruments are so small they can’t cut into tougher tissue like bone and cartilage. Its just for organs and blood vessels...” So there are very clear applications of what you can and can’t do with the system. Anything beyond those applications, at the moment, could prove harmful to the patient and the system.

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Whose Job is it?

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Intuitive’s responsibilities, are to the safety and the patient. The reliability of the equipment, and the training of staff to competently use the system. The company maintains a large portion of its staff around the world to fulfill these responsibilities. Once a problem is Identified, an engineer, or technician team that is assigned to that specific account, arrives to fix, maintain, or replace the robot on a regular basis. Their Sales team’s are also in charge of making sure that the Surgeons are adequately trained in Da Vinci. With all this support, Intuitive provides all it can to insure the safety of the patient through proper maintenance and training. However, it is also noted that the responsibilities of the hospital and the surgeons are just as important to a safe pro-cedure, as a well-checked out piece of equipment. The Hospital, where a Da Vinci system is to be implemented, is responsible for making sure that the required staff are properly educated and qualified with the equip-ment they are using, and the tools they might see. It is there job to notify potential pa-tients of the most experienced surgeon, who is the most qualified for their particular surgery. It has been suggested that, a portion of the reported problems involving the Da Vinci robot, where possibly on the error of an inexperienced, or untrained surgeon attempting to use the robot. Being the most likely cause, since the Da Vinci system and it’s technology has been around for almost 3 decades.

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“Its always good to ask surgeons how many procedures have you done because there are varying degrees of experience and its always good, particularly if you have a com-plex problem to work with a surgeon that has done a greater amount of procedures over a doctor that has done fewer. Not saying that less experience robotic surgeons would do a bad job but they would tend to work on simpler cases and less complex procedures. So as a surgeon becomes more experienced they will take on the more complex procedures and do a good job... So is it [Da Vinci] in its infancy, yes definite-ly. Is it a solid and proven effective tool, yes definitely.” (Mr.Manke)

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Conclusion The Da Vinci is a respectable, and efficient, piece of equipment. Prov-

en to be successful in the right hands; It is imperative, however, that a sys-

tem of regulation be introduced, to make sure that Intuitive is not only

meeting its responsibilities of adequate training for the surgeons, but also

to regulate and make sure that those surgeons using the system are prop-

erly trained and qualified for the procedure.With the Da Vinci system still

improving and developing, the medical industry will begin to implement

even more revolutionary ideas, some with even less time being developed

than Da Vinci. Still, as potential customer it pays to be wary of the poten-

tial benefits and risks. So if you ever do find yourself in Robotic Surgery,

know that you are in good ‘hands’.

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Bibliography

Manke, James. Personal interview. 17 March 2013.

Shaw, Ryan. Personal interview. 27 March 2013.

“Da Vinci is born.” Intuitive Surgical. Intuitive Surgical. Web. http://www.intuitivesurgical.com/company/history/is_born.html

“The Slow Rise of the Robot Surgeon.” Emily Singer. MIT technology Review. March 24, 2010 http://www.technologyreview.com/news/418141/the-slow-rise-of-the-robot-surgeon

“Robotic surgery training and performance.” K. Narazaki, D. Oleynikov, N. Stergiou. University of Nebraska Medical Center. 7 December 2005 http://www.unomaha.edu/biomech/pdf/Narazaki%2006%20Robotic.pdf

“A Consensus Document on Robotic Surgery.” Daniel M. Herron, Michael Marohn. The SAGES-MIRA Robotic Surgery Consensus Group. http://www.sages.org/publications/guidelines/consensus-document-robotic-surgery

“Intuitive Robot Probe Threatens Trend-Setting Surgeries.” Robert Langreth. Bloomberg. March 1, 2013 http://www.bloomberg.com/news/2013-02-28/intuitive-surgical-robots-probed-by-u-s-in-survey-of-surgeons. html?cmpid=yhoo