The use of high-tech medical devices in surgeries performed in New Jersey hospitals and other medical facilities nationally “is exploding,” notes a recent media article that is most specifically centered on robot-assisted surgery.

The medical device maker Intuitive Surgical Inc. has a virtual monopoly on robot-aided procedures, with its da Vinci robotic surgery system reportedly being used in more than 350,000 surgeries across the country last year.

A fundamental question many would-be patients and other persons might have related to such high use is obviously this: How safe is robotic surgery?

The answer to that question most decidedly varies depending on the party being asked. Unsurprisingly, Intuitive Surgical Inc. executives tout their system and stand by the product, whereas a number of critics point to myriad concerns associated with it.

“Robotic surgery … is the poster child for what the concerns are,” says one surgeon. His comment specifically addresses a point made by many commentators on the subject of medical devices, namely, that a proliferation of new operating room technologies is outpacing the ability of researchers to study their real efficacy in surgical outcomes.

Put another way: Surgical errors are reportedly on the rise with the da Vinci tool, and it is not at all clear that the FDA is mustering up a sufficient response to the problem.

One review of surgical outcomes using the da Vinci system found “dozens of injuries that went unreported for years.” An FDA official told Bloomberg News last year that reported adverse events associated with robot-aided surgeries increased more than twofold from 2012 to 2013.

Critics are calling for closer FDA oversight, along with improvements to the federal government’s adverse event reporting system.

One health expert calls that system — a database serving as a massive repository for collecting adverse medical-outcome information — “a disaster.”

Source: Bangor Daily News, “Unreported robot surgery injuries open new questions for FDA,” Robert Langreth, Dec. 31, 2013