The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the trigger of the device was not moving smoothly.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi ¿ (b)(4).
|
It was reported from (b)(6) that during service and evaluation, it was determined that the handpiece device failed lid leak tightness test, the housing was cracked/damaged, the mechanics seized, and the trigger was not moving smoothly.It was noted that the device was blocked because of pollution, the trigger was jammed, the machine was leaking, and the housing was damaged.It was further determined that the device failed pretest for check fitting of the lids, check falling out protection (steal ring), check for roundness, check of free moving, check proper function of the triggers, check for leakage.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, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|