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 the cable/cord/wiring was damaged on the motor device.It was further determined that the motor and control were defective and the hose was worn.It was further determined during the pre-repair diagnostics assessment that the device failed for motor thermistor, handpiece temperature and for air pump assessment.It was noted on the service order that the device had a torn hose, was heating up, and the motor was noisy.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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