It was reported by (b)(6) that during service and evaluation, it was determined that the motor device experienced vibration, abnormal and excessive noise, and the set screw was loose.It was further observed that the cord was damaged, the hose had a hole in it, and the labeling had an illegible etch.It was further determined that the device failed pretest for visual assessments, loctite assessment and noise assessment.It was noted in the service order that the hose 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.The 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.
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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 device experiencing vibration, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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