Udi: (b)(4).The actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the craniotome device tip was bent / damaged, the ball bearing fell apart and the craniotome holder was damaged.It was further determined that the device failed pretest for temperature, visual assessment and cutter insertion.It was noted in the service order that the device was not working anymore.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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