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Unreported robot surgery injuries open new questions for FDA

Bangor Daily News / Bloomberg News, December 31, 2013

A Bloomberg review of reports for operations with Intuitive’s robotic system found dozens of injuries that went unreported for years. Meanwhile, details of other patient problems involving use of the company’s product, cited in legal papers or in interviews with patients, were missing entirely. "The adverse event reporting system is a disaster," said David Challoner, vice president emeritus for health affairs at the University of Florida, who co-authored an Institute of Medicine report urging an overhaul of the FDA's system for regulating and monitoring devices. "Every link in the chain has a reason not to report."