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.However, the assignable root cause could not be established.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
|
It was reported from the (b)(6) that during service and evaluation, it was determined that the handpiece device failed lid leak tightness test, the trigger of the device was not moving smoothly, the labeling was damaged, and the device would not hold/secure the battery.It was further determined that the device failed pretest for check falling out protection (steal ring), check proper function of the triggers, marking and labeling, and check for leakage.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.The exact date of the event was not reported, however, it was reported that the event occurred in (b)(6) of 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|