Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned autotome rx 49 was analyzed, and a visual evaluation noted that the cutting wire was broken, and it was not returned.The proximal end of the cutting wire was blackened.The distal tip of the working length was checked under magnification, and the proximal pierced hole was torn.Additionally, the unit was cut to check the anchor, and it was noted that the cutting wire was broken, and the anchor had remains of the cutting wire inside.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem could have been generated if the device was energized prior to performing sphincterotomy, which can compromise the cutting wire's integrity, and premature cutting wire fatigue.Also, if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure as per precautions of the device states.Once the cutting wire breaks, and if the handle was actuated or any contact between the broken wire and the extrusion, it can tear the proximal pierced hole.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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