Olympus failed to report over 800 overseas medical device defects

24, Jan. 2019

Olympus President Hiroyuki Sasa, left, and Vice President Yasuo Takeuchi at a press conference in Tokyo on Jan. 11, 2019, at which Takeuchi's promotion to president on April 1 was announced.
Olympus President Hiroyuki Sasa, left, and Vice President Yasuo Takeuchi at a press conference in Tokyo on Jan. 11, 2019, at which Takeuchi's promotion to president on April 1 was announced.

TOKYO, Kyodo - Olympus Corp. failed to report 853 medical device defects to the Japanese health ministry that occurred overseas between 2010 to 2017, according to the findings of a group of international journalists.

The unreported cases include more than 300 incidents linked to the company's TJF-Q180V duodenoscopes, which were alleged to have caused drug-resistant superbug infections in more than 190 individuals in Europe and the United States.

An Olympus in-house report compiled by an independent lawyer and not publically available attributed the failure to the Japanese optical equipment maker's incorrect advice to workers that they were not required to report incidences of defects that occurred overseas if a product is not sold in Japan.

However, the report also indicated there may have been a culture that encouraged a "coverup," quoting an official in charge of the matter. It cited another official's comment that the company did not have a proactive attitude regarding reporting.

Under Japan's medical device safety law, manufacturers must report adverse events that can negatively impact patient health to the Ministry of Health, Labor and Welfare. Reports are also required if a doctor using a device is responsible for a problem.

According to guidelines, incidents of defects overseas must be reported if a device has been approved for use in Japan.

Olympus included the overseas cases in its 2017 report to the ministry and apologized.

The company's press office said it "sincerely accepts" the findings and is "actively engaged in complying with the law."

According to the company, it drew up an instruction in 2010 that stated it was unnecessary to report overseas defects if the products were sold outside of Japan.

This was corrected after the health ministry pointed out the problem in 2017.

The latest revelations are linked to an investigation by the International Consortium of Investigative Journalists.

The ICIJ has been investigating the problem of flawed medical devices since 2018, partnering with media outlets worldwide including Kyodo News, The Asahi Shimbun and NHK from Japan.

Lawsuits seeking compensation over the superbug infections have been brought against Olympus in the United States.

The company has also been fined around 9.7 billion yen ($88 million) by the U.S. Justice Department for failing to report the infections even though it was aware of them. (Kyodo)