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Home » Duodenoscope Maker Olympus Fails to Submit MDRs

Duodenoscope Maker Olympus Fails to Submit MDRs

September 1, 2020

Failure to submit medical device reports (MDRs) to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, Calif., facility.

FDA investigators found that the firm failed to submit MDRs to the agency within the required 30-day timeframe.  Some complaints were identified during a complaint backlog review that was initiated as part of a corrective and preventive action.

One complaint related to a guidewire that stuck to a stent during a cystoscopy procedure, and another involved the failure of a grip that required replacement of the device during surgery.

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