Udi: (b)(4).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 component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
It was reported from (b)(6) that during service and evaluation, it was determined that the battery oscillator device would not run and the trigger was defective.It was further determined that the device failed pretest for functional test and trigger test.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 become available, a supplemental medwatch will be submitted accordingly.
|