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 traced to the environment, which is environmental conditions.Udi: (b)(4).
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It was reported by (b)(6) that during service and evaluation, it was determined that the electric pen drive device had unintended activation/motion, corrosion/rusting/pitting, could not control/change speed, mode switch resistance was too high, cosmetic damage and component damaged.It was further determined that the device failed pretest for general condition, check the cable coupling, check function with test hand switch, check for unintended motion, functional test fwd (forward) and rev (reverse) running, check function with foot pedal, check power with power test bench (test could not be preformed) and check speed with tachometer (test could not be preformed).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 unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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