Hospitals Often Don't Report Robotic Surgery Adverse Events

Ashley Gold | FierceHealth IT | January 2, 2014

While the U.S. Food and Drug Administration oversees a database that reports deaths and injuries associated with medical devices, the agency has no authority to force medical providers to contribute to the database. To that end, many hospitals fail to report adverse events associated with robotic surgery procedures, according to a recent Bloomberg investigation.

Patient problems detailed in legal papers and in interviews with patients are missing entirely from the database, according to Bloomberg.

"The adverse event reporting system is a disaster," David Challoner, vice president emeritus for health affairs at the University of Florida, told Bloomberg. "Every link in the chain has a reason not to report."

William Maisel, chief scientist at the FDA's Center Devices and Radiological Health, told Bloomberg that his agency is "well aware of under-reporting of adverse events" and is working to improve the system.