Additional narrative: (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 handling which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring was damaged on the motor device.It was further observed that the motor and control were defective, an error e6 was displayed, the coupling was worn out, the device was getting hot, and the cover was missing.It was also noted that the device failed pre-test for loctite and cable assessments and safety.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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