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 actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to user.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 had labeling damage, sticky trigger, trigger fracture, component damage and illegible etch.It was further determined that the device failed pretest for triggers, marking and labeling and general condition.It was noted in the service order that the device did not work.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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