Olympus Warned Over Endoscope Linked to ‘Superbug’ Infection in U.S.

New York (PNA/Kyodo) — Olympus Corp. has been issued a warning by U.S. regulators for failing to promptly report a “superbug” bacterial infection linked to one of the company’s endoscopes and told to take remedial steps.

The Food and Drug Administration issued the warning in a letter to the Japanese firm’s U.S. unit Olympus Medical Systems Corp., dated last Wednesday and released on the agency’s website Monday.

The letter blamed Olympus for, among other things, failing to report to the agency within the required 30 days after it became aware in May 2012 that an endoscope it sells may have caused a superbug outbreak. Olympus only reported the case to FDA in 2015, according to the letter. (PNA/Kyodo) JBP/PJN