(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 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 on the compact air drive device was blocked, had seized and running rough.It was also observed that the device failed the following pre-tests: check attachment coupling with attachments, check air hose coupling, check for air leak, check function of soft mode switch (safety system), check triggers for fwd i rev mode, check for untrue running, check for excessive noise, check the power with test bench: min.110 to 160 w 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.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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