(b)(4).Reporter's phone number:(b)(6).The manufacturing location was unknown.Device manufacture date is unknown.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 the compact air drive device had an undetermined malfunction.During service and evaluation, it was observed that the compact air drive device motor had seized, jammed and was moving heavy.It was further determined that the device failed the following pre-tests: check for air leak, check triggers for fwd/rev mode, check for untrue running, check for excessive noise, check the power with test bench and check starting behavior.This event did not occur during surgery.There was no patient involvement.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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