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 and a sticky trigger.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.(b)(4).
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It was reported from russia that during service and evaluation, it was determined that the battery reamer/drill device had insufficient/low power, corrosion/rusting/pitting, a worn seal, corroded bearing, a sticky trigger, and component damage.It was further determined that the device failed pretest for general condition, check for sticky triggers, and check power with power test bench.It was noted in the service order that the equipment 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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