Udi not available for this system at time of filing.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.
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Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that during a procedure, the straight suction would not verify.Following procedure, it was verified the suction was bent.It was indicated the procedure had proceeded with the use of the straight suction not navigated.There was no impact to the patient outcome and no delay due to the reported issue.No complications were reported/anticipated.
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