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FDA Probes Docs Over da Vinci Robot Problems

Joe Cantlupe, for HealthLeaders Media, April 25, 2013

No medical device dominates the news as much as the multi-armed robot, particularly the da Vinci, which is at once fiercely loved and incredibly despised.

Some doctors tell me it's the greatest tool they've got to improve efficiencies in the operating room. Others say it's a disaster waiting to happen. In some instances, they believe it already has. While some hospitals are counting on the robot for higher ROI, a growing number of lawsuits is taking center stage over allegations of improper procedures.

In the meantime, the federal Food and Drug Administration has launched a survey to evaluate the robot, focusing on physicians' opinions about the device.

Indeed, the controversy isn't just about the mechanics of the device itself. Often, the robot problems are associated with physician training. Questions about training involving the manufacturer have been raised and there have been allegations of physicians mishandling the device.

The FDA acknowledges there have been increasing reports of adverse events related to the da Vinci, and agency officials want to talk to surgeons about the reasons behind the complaints. Are physicians to blame? Are the robots to blame?

Federal officials have begun a survey of physicians "after we observed an increase in the number of (adverse events) we received about the da Vinci surgical system," FDA spokeswoman Synim Rivers told me.

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