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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the hose of the device was damaged and there was vibration.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor device had cord damage, vibration, illegible etching, the connector was loose, abnormal/excessive noise, and component damage.It was further determined that the device failed pretest for visual assessment, noise assessment, and air pump assessment.It was noted in the service order that the device 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 not reported, however, it was reported that the event occurred in (b)(6) 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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