Additional narrative: (b)(4).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 worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
It was reported that the attachment device had an unspecified malfunction "bearings." during an in-house engineering evaluation, it was observed that the device had vibration and the bearings were worn out.It was not reported whether the event occurred during surgery.It was reported that there were no delays due to the reported event.It was not reported if a spare device was available for use.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.
|