It was reported from (b)(6) that during service and evaluation, it was determined that the compact air drive device had a worn motor, component damage, locking mechanism was stiff/stuck, insufficient/low power, and was leaking air.It was further determined that the device failed pretest for general condition, check the attachment coupling, check attachment coupling with oscillating drill attachment, check reverse locking mechanism with oscillating saw attachment, check the power with power test bench, and check for air leak.It was noted in the service order that the device had an undetermined malfunction.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 2021.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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had insufficient/low power.Therefore, the reported condition that the device had an undetermined malfunction was confirmed.The assignable root cause was determined to be traced to user, which is user error.(b)(4).
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