It was reported by (b)(6) that during service and evaluation, it was determined that the compact air drive device produced excessive noise, would not reverse-reverse locking mechanism blocked, leaked air, had insufficient/low power, would not run and had component damage.It was further determined that the device failed pretest for general condition, check attachment coupling with oscillating drill attachment, check reverse locking mechanism with oscillating saw attachment ii, check forward & reverse mode function, check for noticeable noise, check the power with power test bench and check for air leak.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 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 reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).
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