Olympus instructs employees to conceal report medical device defects

[Xinhua Newsletter] An internal report from Olympus Japan shows that the optical equipment company has instructed employees “conceal report” defects in exported medical devices.

Olympus commissioned an independent practicing lawyer to write this report. The International Consortium of Investigative Journalists and a number of Japanese media quoted reports on the 23rd that companies "mistakenly advised" employees that if the medical devices they produced were not sold in the Japanese domestic market, there was no need to issue a defect report.

Olympus concealed 853 export medical device defects from the Japanese government from 2010 to 2017.Among them, 300 were associated with the "TJF-Q180V" type duodenal endoscope produced by this company.This type of device was put into use in Europe and the United States, resulting in drug-resistant infections in more than 190 patients.

The Japanese Medical Device Safety Law stipulates that once a medical device produced by an enterprise has an "adverse event" that is harmful to the health of the patient,It must be reported to the Ministry of Health, Labour and Welfare; if a device is listed in Japan, it must be reported even if the defect appears overseas.

The report said that a government official in charge of the defect report said that Olympus has a culture of encouraging employees to "conceal mistakes."Another official said that Olympus "has no positive attitude" on the report.

The US Department of Justice issued a $9.7 billion fine to Olympus at the end of 2018 to punish the company for knowing that endoscopic defects caused infection, but did not report it to US regulators. (Zhao Manjun)