(b)(4).(b)(6).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 wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported from (b)(6) that the motor device lever lock was defective, the motor was heating up, and there was noise.During service and evaluation, it was observed that the device had a damaged component; cable/cord/wiring.It was noted that the motor and control were defective, the coupling was blocked, and the motor was blocked, no test run was possible.It was further noted that the device failed pre-repair diagnostic tests for cutter lock assessment, and motor thermistor.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.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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