Only 11 Surgeons Respond to FDA Survey on Da Vinci Surgery

November 11, 2013

During the past several years, a harsh spotlight has shone on the da Vinci robotic surgical system in the form of adverse events (AEs) reports filed with the government, academic studies, news stories, and dozens of lawsuits. Questions swirl around the technology's safety and cost-effectiveness.

The US Food and Drug Administration (FDA) released the results on November 8 of a survey of da Vinci surgeons earlier this year, undertaken to better understand the system's strengths and weaknesses. The responses were mostly positive and few in number — only 11 surgeons turned in answers.

The FDA acknowledged that a "small convenience sample of respondents" was a limitation. The manufacturer of the robotic surgery system, Intuitive Surgical, agreed.

"While we are pleased with the surveyed surgeons' very positive observations about the benefits of robotic surgery, this small informal survey cannot serve as the basis for any scientifically valid conclusions," the company said in a statement issued to Medscape Medical News. It noted that "large clinical studies have documented the comparative benefits of robotic surgery."

The number of procedures performed with the da Vinci Surgical System suggests a sizable cadre of da Vinci surgeons. First approved by the FDA in 2000, the da Vinci Surgical System was used to perform some 367,000 procedures in the United States last year, most of them gynecologic or urologic in nature, according to the company. There were 2042 da Vinci systems installed in US healthcare facilities as of September 30.

The computerized technology allows a surgeon to manipulate laparoscopic instruments attached to robotic arms while viewing the procedure in 3 dimensions, just as if it were open surgery.

Six of the 11 surgeons who responded to the FDA survey practiced at healthcare institutions participating in the agency's Medical Product Safety Network (MedSun); the remaining surgeons were selected on the basis of referrals.

FDA spokesperson Erica Jefferson told Medscape Medical News that the agency does not conduct MedSun surveys "with the intention of them being large in scale."

"They are surveys that we can employ as part of routine surveillance and are one of several postmarket tools FDA uses to help evaluate device use and performance and to further understand the risk–benefit profile for devices," said Jefferson. "So we'd never rely solely on the findings of the survey itself. The number isn't as important as the feedback we're able to glean from those that do respond."

Burns, Cuts, and Punctures

The FDA initiated the survey in January, after it saw a 34% spike in AE reports — including some involving injuries and death — filed with the FDA's Manufacturer and User Facility Device Experience database from 2011 to 2012. The number of da Vinci procedures during that period increased 26%.

Mishaps on file include accidental electrical burns, severed nerves and blood vessels, and punctured bladders. Critics of the da Vinci Surgical System say such mistakes are happening in part because surgeons operating the robotic arms lack haptic feedback.

The FDA noted that the submission of an AE report does not necessarily mean that the device is faulty or defective. In addition, an increase in AE reports may simply reflect an increase in the number of procedures, publicity from product recalls, media coverage, and litigation.

Intuitive Surgical knows about litigation. The company is defending itself in some 50 product liability lawsuits, with plaintiffs' attorneys "engaged in well-funded national advertising campaigns" to solicit even more clients with injury claims, according to a quarterly company report filed with the US Securities and Exchange Commission for the third quarter of 2013. Plaintiffs blame their injuries on alleged product defects and ill-trained surgeons.

The company came out on top in a well-publicized case in Washington State. A jury there found that Intuitive Surgical was not liable for the death of a man who underwent da Vinci–style prostate surgery. Lawyers for the man's estate failed to convince the jury that the company had not properly trained the surgeon to use its technology.

Obesity May Be an Issue

Overall, the results of the FDA survey released today shed a benign light on da Vinci surgery.

All 11 responding surgeons reported "fewer patient complications and shorter hospital stays as a benefit of surgery." The FDA qualified that finding by noting that when surgeons discussed patient outcomes, it was not always apparent whether they were comparing da Vinci surgery with laparoscopic surgery or open surgery.

Sometimes surgeons performing a da Vinci procedure will switch to open surgery when a problem arises. However, surgeons in the FDA survey who have had to make this switch generally cited the patient's anatomy or comorbidities, rather than an equipment issue, as the reason why.

The surgeons mentioned some of the same product failings described in the AE reports submitted to the FDA. These included electrical arcing of monopolar shears, drift in a robotic arm during a procedure, and excessive collision of robotic arms.

The FDA asked the surgeons about appropriate candidates for da Vinci surgery. Two urologists expressed worries about performing prostatectomies in obese men. For the lone cardiothoracic surgeon interviewed by the FDA, obesity was a common reason for turning patients down for coronary artery bypass surgery with this method.

The FDA received numerous suggestions from the surgeons on how to improve da Vinci surgery. Some centered on the technology itself: smaller robotic arms, smaller surgical instruments, and the addition of haptic or tactile feedback. The surgeons also recommended that da Vinci users receive more dry-lab training and log a mandated number of hours for simulation training.

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