Mishaps and deaths caused by surgical robots going underreported to FDA | PBS NewsHour

Not a best practice in government risk management:

The study, published in the Journal for Healthcare Quality earlier this year, focused on incidents involving Intuitive Surgical's da Vinci Robotic Surgical System over nearly 12 years, scrubbing through several data bases to find troubled outcomes. Researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries. But they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all.  The FDA assesses and approves products based on reported device-related complications. If a medical device malfunctions, hospitals are required to report the incident to the manufacturer, which then reports it to the agency. The FDA, in turn, creates a report for its Manufacturer and User Facility Device Experience database....
Makary and his co-authors noted an earlier finding that "among the 37 percent of U.S. hospitals that describe robotic surgery on their hospital website, none mentioned any potential risks or complications.
"We rely on a haphazard reporting system that uses immature data and only the best experiences make it into the data," Makary said. "We introduce things but we don't evaluate them very well. If we're relying on the FDA about what (products) are superior, then we need a new process...you can't make conclusions on the safety profile of a device based on a shoddy reporting system."


Mishaps and deaths caused by surgical robots going underreported to FDA | PBS NewsHour