(b)(4).(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 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 during service and evaluation, it was observed that the motor device temperature was above specification and the coupling was worn.It was further determined that the device failed the following pre-tests: handpiece temperature and safety.It was unknown if the event occurred during surgery or if there was patient involvement.It was unknown if there were any delays to the surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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