Intuitive Surgical's robot surgery injuries went unreported for years, report says

Dozens of injuries involving Intuitive Surgical's ($ISRG) da Vinci surgical robots went unreported to the FDA for years, Bloomberg has found. Many other details involving patient problems with the system were missing from the agency's database entirely, though they subsequently cropped up in legal documents or after interviews with patients, the news service said. Some experts argue that the discrepancies point to major flaws with the FDA's adverse event reporting system, which doesn't force doctors to contribute data. Regulators insist they are working to improve the process and that the system can still function well even in the face of under-reporting of adverse events, according to the story. The FDA disclosed in December that California-based Intuitive issued a global recall involving more than 1,300 robot arms from its da Vinci systems because some may be producing too much friction, causing the da Vinci to briefly stop working. The problems cap a year in which the FDA handled a significantly larger number of adverse event reports relating to Intuitive's surgical robots. Story

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