FDA Tightens Scrutiny of Surgical Robot

Move comes after increase of reports in problems

By Matt Cantor,  Newser Staff

Posted Apr 9, 2013 2:42 PM CDT

(Newser) – You may not have heard of the da Vinci surgical robot, but your local hospital surely has. The $1.5 million robot is a hot item in the medical world, having been used in 367,000 US surgeries last year. Now, however, the FDA is talking a closer look after an increase in reported problems linked to the device, including five deaths, reports AP. In one case, a woman died after the robot nicked a blood vessel. The device is operated by surgeons, and the story takes pains to note that the robot itself may not be at fault.

The multi-armed robot has also made some bizarre moves during surgeries, including refusing to release tissue it was holding and hitting a patient on the face. These days, da Vinci is being used three times as often as it was four years ago; it's in one of four US hospitals. Some experts say that's partially thanks to extensive marketing. "The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," says one. But the robot's maker, Intuitive Surgical, says "adverse event rates" are "in line with historical trends" after 1.5 million surgeries.

In this photo from video, doctors are seen using the device to perform a surgery.   (AP Photo/Courtesy of Intuitive?Surgical, Inc.)
This 2008 file photo shows the da Vinci surgical robot at a hospital in Pittsburgh.   (AP Photo/Keith Srakocic)
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