Olympus Medical Systems Corp. will pay $85 million to settle federal charges alleging it failed to file adverse event reports regarding bacterial infections linked to its duodenoscopes and continued to sell the devices despite infection risks.
Olympus Medical Systems, a subsidiary of Olympus Corp., and a former senior executive pleaded guilty to distributing misbranded medical devices, according to the DOJ.
As part of the plea deal, Olympus acknowledged it did not submit adverse events reports to the FDA for infection outbreaks that occurred in Europe between 2012-14. The company didn't warn the U.S. about infection risks until 2015, when superbug outbreaks had already occurred in Seattle, Pittsburgh and Los Angeles, according to Reuters.
"Olympus deeply regrets its failure to file and supplement the MDRs identified in the plea agreement and accepts full responsibility for these failures," Hiroyuki Sasa, president and representative director of Olympus Corp., said in a Dec. 10 statement regarding the settlement.
Olympus will pay an $80 million fine and forfeit $5 million to settle the charges. The company said it is also working to improve regulatory processes and that the "investigation did not identify any direct harm to patients as a result of the disclosure failures," according to Olympus' statement.
More articles on clinical leadership and infection control:
South Sudan health teams vaccinated amid Congo's Ebola outbreak
CDC confirms record number of AFM cases: 4 things to know
Long-term care options limited for kids after NJ adenovirus outbreak