(b)(4).(b)(6).The 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 wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by switzerland that during service and evaluation, it was observed that the attachment device had damaged component - bearings, worn drive shaft, and damaged sleeve bearings and connecting axle.It was further noted that the device could not be clamped and failed pre-tests for thimble lock operation and cutter insertion.It was noted in the service order that the device was heating up when in use.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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