(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 duplicated and confirmed.The assignable root cause was determined to be due to normal wear from 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 from (b)(6) that during service and evaluation, it was observed that the attachment device bearings were worn, the black color on the groove of the thimble was missing and the drive shaft and its connection were damaged.It was also noted that the device had strong vibrations during pre-testing.It was reported in the service order that the device was defective.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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