Can Olympus Finally Put Its Scope Problems in the Past?

Olympus has been plagued with lawsuits and criminal investigations stemming from problems with its duodenoscopes for more than three years, but a plea agreement with the U.S. Department of Justice could help Olympus learn from its mistakes and move on. Check out these MD&M West conference sessions featuring the latest regulatory and quality information. MD&M West will be Feb. 5-7, 2019 in Anaheim, CA. The Tokyo, Japan-based company admitted that it failed to file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with its TJF-Q180V duodenoscope. After pleading guilty to three criminal misdemeanors, the company was fined $80 million and ordered to forfeit $5 million. Olympus also agreed to undertake enhanced compliance measures as part of its plea agreement with the DOJ. Hisao Yabe, a former executive based in Japan, also pleaded guilty to one count. He is scheduled to be sentenced March 27, 2019, and faces a maximum penalty of one year in prison. Yabe was the company's quality and environment division manager at the time that the infections occurred. Olympus first disclosed the DOJ investigation in May 2015. Medical device manufacturers are required to file a medical device report (MDR) with FDA in a timely manner (generally within 30 days) after learning about an adverse event. The investigation did not identify any direct harm to patients as a result of the disclosure failures, and Olympus...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Regulatory and Compliance Source Type: news