(b)(4).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 wear 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 from (b)(6) that the craniotome device had damaged bearings.During service and evaluation, it was observed that the device bearings were damaged, the ball bearings were worn, after 60 sec the temperature was already 175 f and the craniotome clamp was bent.It was further determined that the device failed the following pre-tests: visual assessment, vibration and temperature.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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