(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 was damaged on the motor device.It was further determined that the motor and control were defective, hose was damaged and leaking, attachment came off, and handpiece was torn.It was further determined that that the device failed pre-repair diagnostic tests for motor thermistor assessment, handpiece temperature assessment, and air pump assessment.It was noted in the service order "drill returned for repair, wires are exposed".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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