Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned ultratome xl was analyzed, and a visual evaluation noted that there were no visual problems with the device.The device was observed under magnification and the cutting wire was in good condition.A functional evaluation was performed by bowing the device outside and inside the scope.The device bowed and returned from bowed position as intended.No other problems with the device were noted.The reported event of cutting wire break was not confirmed.Upon analysis, it was determined that the device did not have any visual damage, also under magnification it was possible to observe that the cutting wire was in good condition.During functional inspection, the cutting wire bowed as intended, indicating that the cutting wire was not broken.The returned unit did not show evidence of either the alleged problem(s) or any defect which could have contributed to the event.Based on all gathered information, the most probable root cause of this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11 (correction): block b5 (describe event or problem) has been corrected, indicating the anatomy location involved during the procedure.
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