This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.A review of the service history record indicates that the device had not been returned previously for the same malfunction.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 will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the compact air drive device motor was seized, jammed and heavy moving.It was further determined that the device failed pretest for starting behavior, power with the test bench, excessive noise, untrue running, triggers for forward and reverse mode, function of soft mode switch (safety system), air leak, air hose coupling and reverse locking mechanism.It was noted in the service order that the device was not working.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 but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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