Astudy published online in the Journal for Healthcare Quality examined the reporting system for robotic-assisted surgery complications. The researchers crossreferenced reports of robotic-assisted surgery complications in legal documents and the news media with the FDA database of adverse events. They found eight incidents that had not been reported to the FDA, two of which were eventually filed after reports appeared in the press. Currently, hospitals, patients and the robot manufacturer voluntarily report adverse events to the FDA.
From 2000-2012, 245 complications were reported to the FDA, including 71 deaths and 174 nonfatal injuries. “We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there,” study co-author Martin Makary told Medscape Medical News.