The actual device was returned for evaluation.The compact air drive device was evaluated and the reported condition was not working not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the trigger of the device was fractured, and the device had insufficient/low power.The assignable root cause of these conditions was determined to be traced to component failure due to normal wear.Udi: (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the trigger of the compact air drive device was blocked and broken, the reverse lock was blocked, and there was damage to the rear trigger.It was further determined that the motor was worn, the mechanics of the device had seized, the device had insufficient/low power, the device was leaking air, and there was component damage.It was further determined that the device failed pretest for general condition, check reverse locking mechanism, check for function of the device, check forward and reverse mode function, check power with the test bench, and check for air leak.It was noted in the service order that the device was not working, and the black plastic handle was broken.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 the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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