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, 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 from wear.Udi: (b)(4).
|
It was reported by (b)(6) that during service and evaluation, it was determined that the motor device exhibited vibration, produced excessive noise, had 360 degree rotation, had illegible labeling etch, component damage and cord damage.It was further determined that the device failed pretest for visual assessment: (verify that all markings are present and legible) and (verify that the cord is not damaged), loctite assessment and noise assessment.It was noted in the service order that the device swivel rotated.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 (b)(6) 2022.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
|