It has been hailed as a miracle of modern medical science.  But this miracle costs $1.5 million to $3 million depending on the options ordered, and requires its owners to pay over $100,000 or more per year in service agreements, not to mention costs of the one-time-use attachments that are required to maintain and use the da Vinci® Robot.

This miracle is made possible by a company called Intuitive Surgical, Inc., located in Sunnyvale, CA, in fact, the da Vinci® Robot and its various attachments are the company’s only product line.  The da Vinci® is a 3 or 4 robotic armed device controlled by a surgeon sitting at a video console a few feet away from the patient rather than standing over them as in conventional surgeries.  The surgeon controls the robotic arms of the device by hand and foot controllers, rather than conventional surgical instruments.

The device is used for laparoscopic abdominal procedures, such as hysterectomies, prostatectomies, and rectal floor procedures, although it has also been used in repairing heart valves and for organ transplants.  Use of the product has increased worldwide since its approval by the FDA in 2000.  In 2012, nearly 400,000 surgeries were performed in the U.S. using a da Vinci® device, an increase of approximately 70,000 over 2011.

From 2011 to 2012 the number of Adverse Event Reports (AER) received by the FDA regarding this product increased disproportionally higher than the increase in procedures performed.  Perhaps in response to this increase, the FDA initiated a survey of surgeons in January of 2013.  As part of this survey, the FDA sent letters to surgeons who work at hospitals that participate in the FDA’s Medical Product Safety Network (MEDSUN).

The survey asked several questions, among them being:

  • How many surgeries and what type of surgeries have you performed using the da Vinci® surgical system over the last three years?
  • What procedures do you believe are most suited, or least suited for the da Vinci®?
  • How are patients selected for procedures using the da Vinci® system?
  • Do you prefer the da Vinci® system to conventional systems?
  • What “kind of complications” are you seeing?
  • How is training usually conducted and how often does it occur?

While the FDA is remaining silent on the outcome of this survey and any other surveillance it may be conducting on this product for now, many cases are working their way through the courts, which may help determine the future of this product and how and when it is used.

Intuitive Surgical spokesperson, Geoff Curtis, downplayed the FDA’s actions as “routine.”  The da Vinci® product line “…has an excellent safety record, with more than 1.5 million surgeries performed globally, and total adverse events have remained low and in line with historical trends.”  Curtis related that the company has investigated all the AER’s, and “…to date, there have been no confirmed incidents where the computer went out of control to produce an unintended motion.”

This statement may be true as far as it goes, but perhaps the case of the da Vinci® Robot which wouldn’t perform an intended motion illustrates a point.  One of the AER reports relates to an issue where the grasper wouldn’t let go of a patient’s tissue.  “We had to do a total system shutdown to get the grasper to open its jaws,” the report states.  There are other reports of unintended cauterization of a fallopian tube, and multiple reports of electrical arcing from the monopolar attachments to exposed patient tissue.

A Washington State Court case, titled, “Estate of Fred E. Taylor v. Intuitive Surgical Inc., 09-2-03136-5, Superior Court, State of Washington,” maintains that Intuitive Surgical did not provide proper training for an experienced surgeon who had performed over 100 successful conventional prostatectomies, but after his first da Vinci® procedure, the patient died.  This and a dozen or so other cases are currently in litigation across the country as a result of injury or death involving the da Vinci® device.

While the FDA evaluates what its next step is with this new product, various state agencies are also weighing in.  Perhaps the Massachusetts Board of Registration in Medicine’s recent advisory summarizes the situation well:

“As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection, and the full explanation of risks and benefits for all surgical options.

“Patients should be advised on the experience of the surgeon in performing the recommended robotic procedure.”

Sources:

www.medscape.com/viewarticle/803339

http://www.bloomberg.com/news/2013-04-15/intuitive-s-first-robot-surgery-trial-to-probe-training.html