TOKYO, Dec. 10, 2018 /PRNewswire/ -- Olympus Medical Systems Corporation, a subsidiary of Olympus Corporation, today finalized a plea agreement with the U.S. Department of Justice (DOJ) on issues related to filing and supplementing Medical Device Reports (MDRs) for Olympus's TJF-Q180V duodenoscopes. The DOJ investigation was first disclosed by the Company in May 2015.
In the plea agreement, Olympus acknowledged that it failed to submit two required supplemental MDRs and one initial MDR to the U.S. Food and Drug Administration (FDA) for events in Europe between August 2012 and October 2014. The Company agreed to plead guilty to three criminal misdemeanors in the U.S. District Court for the District of New Jersey. Additionally, the Company agreed to pay a fine and forfeiture totaling approximately $85 million, to undertake new steps to enhance its regulatory affairs processes and procedures, and to regularly make certain certifications that the Company is meeting the expectations of the settlement.
The investigation did not identify any direct harm to patients as a result of the disclosure failures, and Olympus acknowledged that it failed to comply with the federal reporting requirements. The settlement does not impact the availability of Olympus products and services worldwide.
"Olympus deeply regrets its failure to file and supplement the MDRs identified in the plea agreement and accepts full responsibility for these failures," said Hiroyuki Sasa, President and Representative Director, Olympus Corporation.
In the years since these events occurred, as the DOJ said in court, Olympus has made "notable compliance improvements" such as significantly enhancing its regulatory affairs function, including reorganizing and enhancing the global regulatory affairs department, adding reporting and supervisory personnel, restructuring the organization to promote greater communication and accountability, and increasing training for personnel.
"Patient safety is the guiding principle of Olympus's mission to help people around the world lead safer, healthier and more fulfilling lives," said Mr. Sasa. "Through the development and improvement of our next generation of products, continuously updating and providing guidance on best practices regarding the safe and effective use of our products, and working with our stakeholders to improve the effectiveness of endoscope reprocessing, Olympus is committed to fulfilling its mission."
About Olympus Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our nearly 100-year history, Olympus has focused on being true to society and making people's lives healthier, safer and more fulfilling.
Our medical business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients.