Duodenoscope Maker Olympus Fails to Submit MDRs

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.