(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 the motor device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that there was damaged component to the cable/cord/wiring.It was further determined that the device displayed an e6 error code, the control had a crack, the motor had no function and the hose was worn out.It was further determined that the device failed for loctite and cable assessments.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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