FDA issues Warnings to Duodenoscope Makers

On August 12, 2015, olympusthe FDA issued warnings to several duodenoscope makers: Olympus Corporation of the Americas, Fujifilm Medical Systems and Hoya (Pentax) Corporation.

Olympus Corp., the U.S. subsidiary of the Japanese scope maker, said in February 2015 that the Justice Department had been investigating its medical business since November 2011.

UCLA reported that the CRE superbug possibly infected nearly 200 UCLA patients. Olympus manufactured the scopes that medical officials believe infected seven patients at UCLA’s Medical Center with a drug-resistant bacteria. Two of those people died.

FDA warned hospitals and physicians in February 2015 that the commonly used medical scopes may have spawned the superbug outbreak at UCLA.