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 undetermined.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 repair, it was observed that the battery reamer / drill device was found with jammed triggers and a defective motor, and control unit with blood in the transmission.This event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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