Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The 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 traced to component failure due to normal wear.Reporter number extension: (b)(6).Udi: (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the air reamer device made excessive noise, was leaking air, had low power, the moving parts did not move smoothly, the etching was illegible, had component damage and was worn.It was further determined that the device failed pretest for check for noticeable noise, check for air leak, check starting behaviour, check power with power test bench, check for mechanical free movement, marking & labeling and general condition.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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