Additional narrative: (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 duplicated and confirmed.The assignable root cause was determined to be due to improper reprocessing, 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 from (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring was damaged on the motor device.It was further determined that the device had liquid damage, the motor and controller were defective, the machine was becoming hot while running and the coupling was worn out.The device was reported to have failed the following pre-tests: temperature, noise and safety.It was noted in the service order that the device was returned for an unspecified malfunction.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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