Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.However, the assignable root cause could not be determined.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 bearing seized, the trigger and moving parts did not move smoothly, would not run, the housing was damaged and failed leak tightness testing.It was further determined that the device failed pretest for check function of device, check for sticky triggers, check for mechanical free moving and leakage test using bubble emission technique.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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