FDA inspectors uncover new violations by manufacturer of scopes linked to superbug outbreaks

IndustriesAssociated Press

Federal regulators have uncovered new violations by the manufacturer of medical scopes recently linked to outbreaks of deadly "superbug" bacteria at U.S. hospitals.

Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company's scope in 2012, according to a warning letter issued Monday by the Food and Drug Administration. Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks.

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Additionally, FDA inspectors say that the company has no procedure for promptly reporting serious problems with its devices, a requirement for medical device makers.

Olympus medical scopes were linked to infections of antibiotic-resistant bacteria at two separate Los Angeles hospitals early this year.