FDA Warns Olympus for Waiting Years to Report Infections

August 17, 2015 — Olympus Corp. waited three years to release reports of patients suffering bacterial infections after being treated with contaminated endoscopes, according to a warning letter issued by the FDA.

In May 2012, Olympus received a complaint that 16 patients developed the bacterial infection Pseudomonas aeruginosa after undergoing endoscopic procedures. Olympus waited until May 2015 to tell the FDA about the outbreak within 30 days.

Two other scope-makers, Fujifilm and Pentax, also received warning letters for violations observed at plants in Japan and the United States earlier this year.

Pentax and Fujifilm were cited for failing to ensure their instructions for cleaning the scopes were actually effective. The FDA told Fujifilm that its newest endoscope does not have proper clearance and they are investigating similar problems with Pentax scopes.

Pentax was also cited for failing to report that their devices “may have caused or contributed to a death or serious injury” within 30 days. The scopes were linked to cases of antibiotic-resistant Carbapenem-resistant Enterobacteriaceae (CRE) infections.

Earlier this year, a duodenoscope made by Olympus was linked to several major outbreaks of antibiotic-resistant infections. At least 13 deaths and dozens of infections have been reported at hospitals in California and Washington.

The FDA warned that the scopes have complex mechanisms that are almost impossible to disinfect completely, even after following the manufacturer’s instructions for cleaning. Furthermore, the Olympus scope had been on the market since 2010 without permission.

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