The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had was making excessive noise and the trigger of the device was not moving smoothly.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery handpiece device failed a lid leak tightness test, was making excessive noise, the trigger of the device was not moving smoothly, and the locking mechanism was stuck/stiff.It was further determined that the device failed pretest for check falling out protection (steal ring), check proper function of the triggers, check the attachment coupling, check for leakage, marking and labeling, and general condition.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 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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