Additional narrative: (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.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 discovered that there was damaged component to the cable/cord/wiring of the motor device.It was further determined that the control had a crack, the motor (driver) and the coupling were defective.It was observed that the hose was worn; the device made metallic noises, the connector cap cover wire cable was missing and the temperature was 119 f to "3 unit s".It was further determined during the pre-repair diagnostics assessment that the device failed for loctite & cable document assessments, handpiece temperature assessment, hand control assessment, noise assessment and for safety 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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