An Olympus Corp. subsidiary pleaded guilty on Monday and agreed to pay $85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections connected to its duodenoscopes while continuing to sell the medical devices used to view the gastrointestinal tract.
Olympus Medical Systems Corp. and Hisao Yabe, a former senior executive at the company in Japan, pleaded guilty in federal court in Newark, New Jersey, to distributing misbranded medical devices, the U.S. Justice Department said.
As part of a defense agreement, the ministry told the President of the US District Court, Stanley Chesler, that Olympus was fined $ 80m and was bound to pay $ 5m in compensation.
On Monday, the US Food and Drug Administration issued a new warning about the threat of continual contamination from reusable duodenoscopes. In preliminary studies, the FDA noted that 3 percent of the samples collected by manufacturers from duodenoscopy were positive for kop high-anxious iler bacteria, such as E. coli, which were often associated with the disease.
Olympus said in a statement that it has agreed to take steps to improve its regulatory processes, and that the investigation does not directly harm patients caused by failure to file the reports.
Yabetus lawyer had no immediate comment. Yabe, 62 is expected to be convicted on 27 March and to be imprisoned for a maximum of one year.
Duodenoscopes are flexible tubes with illuminated video equipment suspended in the patient’s throat to diagnose or treat gastrointestinal disorders.
At least 35 patients in US hospitals have lost their lives since 2013, after developing infections due to contaminated Olympus duodenoscopes according to hospitals and public health officials.
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