As reported, during an endoscopic cholangio-pancreatography therapeutic procedure, at the time of the sphincterotomy of the oddi sphincter, the wire is cut by the electric arc of the knife.The intended procedure was completed using another sphincterotome (similar device) from the same lot without any issue.No patient consequences.There was no patient harm or injury reported due to the event.No user injury reported.
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was returned and an evaluation was completed for it.During inspection, olympus confirmed the reported event, the cutting wire was broken on the proximal side.The broken portion was scorched and melted.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 1 year since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1.The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.2.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.3.The output was activated in state of ¿2¿ description.This might have led to an electrical discharge between the cutting wire and the distal end of the endoscope.4.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That might have caused the cutting wire to break.The following information is stated in the instructions for use (ifu): ¿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.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.¿ olympus will continue to monitor field performance for this device.
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