FDA: scope manufacturer waited years to report problems
WASHINGTON - 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.
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.