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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 posted online 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.
Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them. The infections reported to the company involved a bacterial strain called pseudomonas, which can cause pneumonia, severe sickness and death in hospital patients.
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