Udi: (b)(4).Reporters phone number: (b)(6).Reporters complete address was not provided.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 handling which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that the motor device had a broken hose.During service and evaluation, it was observed that the motor device had a damaged component - locking components, coupling hose worn, hose damaged, pin was loose, and the device was getting hot.It was also noted that the device failed pre-test for loctite and cable, cutter lock, motor thermistor, handpiece temperature, hand control, safety and air pump.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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