The number of complications from robot-assisted surgery using Intuitive Surgical's da Vinci robot are underreported, allege critics of the procedure, fanning the controversy around the company's pioneering product.
The closest to a central database for medical device "adverse events" is the Food and Drug Administration's Manufacturer and User Facility Device Experience—or MAUDE—database.
Since 2000, the database shows reports of at least 85 deaths and 245 injuries related to Intuitive Surgical's da Vinci-related injuries.
During the same period, roughly 1.5 million robotic procedures have been performed. While some would argue that any death or injury could and should be unacceptable, the simple math suggests that reported problems are statistically insignificant in terms of overall risk.
CNBC.com's Da Vinci Debate series:
Part 1: Controversy Over Surgical Robotics Heats Up
Part 2: Patients Scarred After Robotic Surgery
Part 3: Counting the Problems of Robot-Assisted Surgery
Part 4: Marketing Is Key to Surgical Robot's Success
Among the critics: Dr. Marty Makary of Johns Hopkins University Hospital and author of the book, "Unaccountable," who believes the number of injuries and complications are under reported. A study he co-authored, which is under review by the Journal for Healthcare Quality, cross-referenced the FDA's database with press reports and lawsuits and found eight cases that were either incorrectly or never filed with the FDA.
While that may be a "fraction of procedures that are done," said Makary, the industry has done "a poor job of monitoring the safety profile of certain new technologies, and this is a classic example."
Makary, a pancreatic specialist known for doing complicated procedures — and trained on the robot — prefers straight nonrobotic laparoscopy because he says with the robot he is concerned about what he calls "the lack of haptic [tactile] feedback. Because we're working around major blood vessels, an inadvertent injury could result in a catastrophic bleed within seconds."
Yet, he added, "we have not even been keeping a national registry of robotic surgery-related complications. And from the ones that we have, we know from our research there is a massive underreporting."
Meanwhile, the FDA cautions that MAUDE "is not intended to be used to evaluate" rates of adverse events. To do so, Intuitive said, would be "factually and contextually inaccurate."
(Related Article: Robotic Surgery: Growing Sales, but Growing Concerns)