It was reported by (b)(4) that during service and evaluation, it was determined that the motor device had vibration.It was further observed that the device had cord damage, illegible etch, loose connector, set screw and house pin, and cracked/damaged housing.It was also determined that the device was making excessive noise.It was further determined that the device failed pretest for visual assessments, loctite assessments, and noise assessment.It was noted in the service order that the hose of the device was damaged.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.Exact date of the event was unknown.However, it was reported that the event occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, evaluation was performed, it was determined that the reported condition of the device experiencing vibration identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi#: (b)(4).
|