Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported conditions of device generating heat and running in locked position identified during service and evaluation were confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).
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It was reported by india that during service and evaluation, it was determined that the motor device was generating heat and running in locked position.It was further observed that the device was making excessive noise, had cord damage and could not secure/lock cutter.It was further determined that the device failed pretest for visual assessment, cable assessment, cutter lock assessment, safety assessment, noise assessment and handpiece temperature assessment.It was noted in the service order that the device was not working properly.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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