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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.

Read more on www.justice.gov

Action Details

  • Date:December 10, 2018
  • Agency:U.S. Department of Justice
  • Enforcement Types:
    • Criminal and Civil Actions