November 20, 2013, 01:30:00PM. By Heidi Turner
Washington, DC: Patients who have suffered an operating room injury during surgery involving the da Vinci robot may not be surprised by reports that the number of robot-related surgical injuries is on the rise. Concerns about injuries linked to robotic surgery are conveyed in da Vinci robot lawsuits, alleging patients were seriously harmed because of the use of the robot during surgery. Now, preliminary reports from the US Food and Drug Administration (FDA) suggest that such injuries are on the rise.
Information from the FDA, and reported on by The Wall Street Journal (11/17/13) suggests a dramatic increase in adverse events – including injury and death – linked to robot surgery. Data collected by the FDA and analyzed by physicians from Rush University Medical Center, the University of Illinois and the Massachusetts Institute of Technology show an increase from 13.3 adverse event reports per 100,000 procedures in 2004, to 50 reports per 100,000 procedures in 2012.
There were reportedly 282 reports of injury in 2012, including 28 deaths to the FDA. Whether the increase in adverse event reports is because of an actual increase in such events or because more people are reporting injuries and deaths is not clear, but experts agree that the total number of adverse events reported to the FDA is generally much lower than the number of events that occur.
Furthermore, in a document sent by the FDA to Intuitive Surgical, maker of the da Vinci robot, on May 30, 2013, the agency noted that illnesses or injuries that were linked to the robot were not reported to the FDA. The agency also noted that a correction or removal, which was done to reduce the risk of injury linked to the da Vinci robot, was not reported to the agency.