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 of this condition was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).
|
It was reported from (b)(6) that during service and evaluation, it was determined that the trigger of the battery oscillator device was not moving smoothly.It was further determined that the device failed pretest for trigger test and check the saw head.It was noted in the service order that the device was defective.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.
|