Additional narrative: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the motor seized and was rough running.Therefore, the reported condition was confirmed.It was further determined that the motor was blocked.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported from (b)(6) that the power drive device was without power.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays to a scheduled surgical procedure.A spare device was not available for use.It was not reported if there were any 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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