Olympus to pay $85M for failing to report adverse events related to duodenoscopes — 6 insights

Olympus Medical Systems Co., and former Olympus executive Hisao Yabe both pled guilty to failing to report adverse events related to infections connected to Olympus' duodenoscopes.

Here's what you should know:

1. Olympus pled guilty to three counts and Mr. Yabe pled guilty to a single count of distributing misbranded medical devices in interstate commerce.

2. The Department of Justice fined Olympus $80 million and ordered the company to forfeit $5 million.

3. Mr. Yabe also admitted to failing to alert the FDA to the infections. Mr. Yabe was Olympus' Division Manager for the Quality and Environment Division at the time, and the company's top regulatory official.

4. Mr. Yabe could face up to a year in prison and a $100,000 fine. He'll be sentenced in March 2019.

5. Olympus admitted to failing to report adverse events in 2012 and 2013 related to its TJF-Q180V duodenoscope. Approximately 30 patients suffered from infections tied to the duodenoscope.

6. Olympus must also implement extensive compliance reforms.

Olympus did not release a statement related to the settlement, but outlined the deal in a document posted online.

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