Olympus medical systems corp (omsc) was informed that during an endoscopic sphincterotomy (est) with sphincterotome, the cutting wire of the subject device broke.The doctor continued the procedure with another kd-v411m-1530.However, the cutting wire broke again and the broken wire came off into the patient.He removed it with a grasping forceps and used kd-211q-1530 but it broke.He inserted stent and completed the procedure since cutting length of papilla was enough.There was no report of patient injury regarding this event.During the investigation, omsc found the plastic coating on the first cutting wire was partially missing.
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The investigation confirmed that the cutting wire was broken at the coated portion and the broken section was melted and burned.Approximately coating was missing for 5mm from the broken point.Also as a result of checking the manufacturing record of the same lot, nothing abnormal detected.As the results of the investigation, omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while activating the output, which caused spark and a part of the cutting wire became extremely hot, resulting in breakage.The coating broke off and came off from the cutting wire because of the user handling after the cutting wire was broken.
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