(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the attachment device had a cosmetic defect.It was further determined that the warning symbol was missing, drive shaft was worn, and bearings and sleeve were defective.It was noted in the service order that the device had no function.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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