Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections
Olympus Medical Systems Corporation (Olympus) and a former senior executive in Japan pleaded guilty today in Newark, New Jersey, to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the duodenoscopes in the United States despite those failures, the Justice Department announced today.
Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
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