Report Raises Concerns on Robotic Surgery Device

Report Raises Concerns on Robotic Surgery Device

THOMAS M. BURTON

Updated Nov. 8, 2013 8:06 p.m. ET

Surgeons in Paris using the da Vinci Surgical System in March 2012. A new analysis raised safety concerns. ABK/BSIP/Corbis

A robotic-surgery device called the da Vinci Surgical System is linked to “an overall increasing trend in the rate of injury and death reports” since 2004, according to a draft analysis of such events reported to the Food and Drug Administration. The draft analysis, by the chief of adult cardiac surgery at Rush University Medical Center and co-authors from the University of Illinois and Massachusetts Institute of Technology, focused on all adverse-event reports made to the FDA from January 2000 through last December. The da Vinci device is made by Intuitive Surgical Inc., ISRG +2.70% of Sunnyvale, Calif.The company disagreed with the analysis. “Our analysis shows the rate of death is essentially flat, and that the rate of injury varies over time, but that there isn’t any statistically significant trend,” said Dave Rosa, Intuitive’s senior vice president for scientific affairs.

Jai Raman, a Rush surgeon, and co-authors found that 4,798 adverse events were reported in the U.S., including 85 deaths, 414 patient injuries and 3,402 device malfunctions. While the overall rate of events, including malfunctions, declined over the period studied, there was a sharp increase in the injury and death rate to about 50 reports per 100,000 U.S. procedures in 2012, from 13.3 in 2004, the authors concluded. They plan to present their analysis at a medical meeting early next year. The draft analysis was made available to The Wall Street Journal by the authors.

“We found that the rate of injury and death adverse events has actually gone up. That’s the most striking thing,” said Dr. Raman. He said many hospitals that bought the robotic-surgery device did small numbers of hysterectomies, prostatectomies and other operations, and that as a consequence some surgeons haven’t become proficient enough.

FDA officials said they were uncertain as to whether the adverse events represented a true increase in clinical problems or simply an increase in the rate of reporting as the device drew more attention. The FDA said it hasn’t checked medical databases, such as those of insurance companies or of the Department of Veterans Affairs, to discern the reason for the increase.

The FDA grew interested in Intuitive Surgical adverse events in 2011, leading to an inspection this year of the company and a warning letter from the agency. The FDA’s warning letter said the company had made safety changes in the recommended handling of the device because of adverse-event reports but hadn’t reported the changes to the FDA prior to the agency’s inspection this year.

The company said in a recent federal filing that it is correcting any violations that the FDA detected.

Intuitive Surgical said in a government filing that as of Sept. 30 it was defending “about 50” product-liability lawsuits over alleged injuries or deaths from robotic surgery. It said that the number of world-wide robotic surgery procedures grew to 450,000 in 2012 from 360,000 a year earlier. The robotic system sells for between $1 million and $2.3 million.

“We have been monitoring the company and the product,” said William Maisel, chief scientist at the FDA’s center for medical devices. “We believe the products can be used more safely.”

A report in September in the European Journal of Obstetrics & Gynecology and Reproductive Biology raised another issue with the robotic surgery—its cost. “When considering overall medical care, the use of robotic-assisted surgery was found to be 1.6 times more expensive than conventional surgery,” wrote the authors, from the departments of gynecology and obstetrics at Francois-Rabelais University in Tours, France.

That followed a February report in the Journal of the American Medical Association concluding that a robotic hysterectomy cost a hospital $8,868 on average compared with approximately $6,600 for conventional surgery.