Olympus Medical Systems, a unit of Japan’s Olympus, has pleaded guilty and agreed to pay $85m to resolve a criminal probe by the US Department of Justice (DOJ) over infection outbreaks linked to its duodenoscope.
The company pleaded guilty to three counts of distributing misbranded medical devices. A former Japanese executive, Hisao Yabe, pleaded guilty to one count.
Olympus admitted that it failed to file a total of three medical device reports (MDRs) for infection incidents associated with its TJF-Q180V duodenoscopes in Europe between August 2012 and October 2014.
In 2012, the company’s devices were tied with infection of around 27 patients with Pseudomonas aeruginosa as well as Escherichia coli infection in three patients.
DOJ claimed that the company continued to sell the duodenoscopes in the US despite the events. Yabe admitted to his personal responsibility for the failure to file the required information.
Department of Justice Civil Division assistant attorney general Jody Hunt said: “Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the US, can extend and improve the quality of life for many people.
“But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr Yabe put patients’ health at risk.”
The court imposed an $80m fine on to Olympus and ordered a $5m payment in criminal forfeiture.
In addition to the fine, the company also agreed to implement new measures to boost its regulatory affairs processes and procedures. It will also regularly make certifications on meeting the settlement expectations.
Olympus Corporation president and representative director Hiroyuki Sasa added: “Olympus deeply regrets its failure to file and supplement the MDRs identified in the plea agreement and accepts full responsibility for these failures.”
The company added that the probe did not find any direct harm to patients due to the disclosure failures.