Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to component failure (faulty parts), which is normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported by (b)(6) that during service and evaluation, it was determined that the trigger of the battery handpiece/ modular device was sticky.It was determined that the mechanics and gears seized, the bearing was worn, and other mechanisms were damaged.It was further determined that the device failed pretest for check for roundness, check of free moving, check proper function of the triggers, check the cannulation and check history.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 unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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