The single use 3-lumen sphincterotome v (kd-v431m-0720) was returned to the service center for evaluation for the reported event of cutting wire was cut in the center.The returned condition device was visually inspected and the complaint was confirmed.The observation that the metal cutting wire was broken/detached at the flexible distal end.Additionally, the device was inspected under a microscope and observed to have charred marks/dark stains on the wire, which was indicated to be consistent with energy output.No other damages were observed during the inspection.Based upon the evaluation of the returned device, the reported complaint was confirmed and determined to most likely be attributed to device mishandling, in which the cutting wire may have come into contact with a metallic object, resulting in the damages observed.According to the instruction manual, the following statements were provided to the operator to caution during usage; ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong can results in the cutting wire breakage¿.
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