Scopes linked to superbug outbreak lacked FDA clearance

March 4, 2015 10:01 PM

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Scopes linked to superbug outbreak lacked FDA clearance

One of the latest models of a special kind of hard-to-clean endoscope, linked to outbreaks of deadly drug-resistant bacteria in Philadelphia, Los Angeles and elsewhere, was on the market for years without clearance from the Food and Drug Administration, the agency said Wednesday.

Olympus Corp., which has U.S. headquarters in Lehigh County, said it did not seek clearance in 2010 for the duodenoscope because it was not significantly different from a previous version that did have agency clearance.

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