(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 improper reprocessing, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring on the motor device was damaged.It was further determined that there was liquid damage (motor and control defective), the ball bearing drive shaft was broken, the coupling was worn, and the device overheated and was too loud.It was also noted that the device failed pre-repair diagnostic tests for handpiece temperature assessment, and noise assessment.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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