(b)(4).(b)(6).The 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 improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
It was reported by (b)(6) that during service and evaluation, it was observed that the control unit on the electric pen drive device was not functioning.It was further determined that there was a control defect, the housing had sharp edges, the device only ran forward, and the pen was wet.It was further determined that the device failed pre-repair diagnostic tests for general condition, direction of rotation, and function with the foot pedal.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.
|