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.However, the assignable root cause could not be determined.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 cable/cord/wiring was damaged, the device displayed an f8 error, the hose was defective, the coupling was worn, the device was hot, the device was in the current state pull out and the temperature after 5 minutes was 120 degrees fahrenheit on the motor device.The device also failed the following pre-tests: loctite and cable assessments, cutter lock assessment and hand piece temperature assessments.It was noted on the service order that the motor on the device was not working.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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