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FDA: Olympus Was 3 Years Late Reporting Infections Linked To Duodenoscopes

(August 18, 2015, 10:36 AM EDT) -- SILVER SPRING, Md. — Olympus Medical Systems Corp. failed to report infections related to its duodenoscopes for three years, the Food and Drug Administration told the device manufacturer in a warning letter released Aug. 17.

The latter, dated Aug. 12, says Olympus “failed or refused to furnish material or information respecting the device” as required by federal law. It says Olympus failed to report to the FDA within 30 days after the firm became aware of information “that reasonably suggests that a device that your firm...
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