Olympus Corp. is appropriating more than $85 million in expected losses from a federal investigation into the company's duodenoscopes, which have been linked to several infection outbreaks since 2010, reports The Morning Call.
Here are four things to know:
1. Olympus recorded a reserve of about $85.6 million in the second quarter of fiscal year 2019, which ends March 31, according to a financial statement released Nov. 6. The company's exact loss will depend on the federal investigation's outcome, but Olympus said it thinks $85.6 million is "reasonable as expected losses according to the status of the investigation."
2. About 350 patients from 41 healthcare facilities worldwide were either exposed to or infected by contaminated scopes from Jan. 1, 2010, to Oct. 31, 2015, according to an FDA document made public in April 2016. Olympus is the largest duodenoscope manufacturer in the U.S., but Pentax and Fujifilm also sell the scopes.
3. Olympus faced scrutiny over the design of its TJF-Q180V duodenoscope, which made the device difficult to clean and was linked to several antibiotic-resistant outbreaks. The company recalled and redesigned the device in January 2016.
4. The Justice Department subpoenaed Olympus for more information on its scopes in March 2015 and August 2015. Company spokesperson Mark Miller said Olympus "has cooperated fully with the Department of Justice," but declined to share additional information regarding the investigation, according to The Morning Call. The Justice Department did not immediately respond to the publication's request for comment on the investigation.