(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 duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported from (b)(6) that during service and evaluation, it was observed that the motor device cable/cord/wiring, hose and clutch were damaged, the control was defective, the connector cover was missing and the ball bearings were stiff.The device failed the following pre-tests: loctite and cable, motor thermistor, temperature, hand control, safety and air pump assessments.It was reported in the service order that the device had a torn hose.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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