Adverse-Event Reporting Failure Leads To Guilty Plea For Olympus, Exec

Olympus Medical Systems and a former senior executive have pleaded guilty to allegations that they sold duodenoscopes even after failing to submit required adverse-event reports on them.

Duodenoscope manufacturer Olympus Medical Systems Group is facing $85m in penalties after pleading guilty to charges of distributing misbranded medical devices.

The US Department of Justice says that Olympus, as well as senior executive Hisao Yabe, failed to submit adverse event...

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