This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: 1.When the forceps stand of the endoscope was raised, the knife wire where the wire coating was torn came into contact with the tip of the endoscope.2.1.When electricity was applied in this state, the knife wire instantaneously became hot at the contact point, leading to breakage.Based on the result of confirmation of the device, and the similar investigation results in the past, a likely mechanism causing the cutting wire breakage might be the following.1.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.2.Under circumstances described above 1, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.It is likely that the tearing of the wire coating was caused by the following factors.However, the cause could not be determined.- the knife wire was bent due to the slider being pushed a little, and the wire coating came into contact with the metal tip of the endoscope and rubbed (see photos 2 and 3).A likely factor causing tears of the coated portion of the cutting wire might be the following.However, the exact cause could not be determined.·it is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.The event can be detected/prevented by following the instructions for use which state: "¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting wire is very short, the output is too high or activated while the cutting wire touches metal parts of the endoscope, or the cutting wire is tightened too strong.When the cutting wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the cutting wire will be pushed out toward the papilla or move sideways.If the cutting wire breaks off, stop the output immediately and pull the slider completely to retract the broken cutting wire into the tube.Then withdraw the sphincterotome from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct, and/or damage of the endoscope could result.¿ when inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube.Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material.¿do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end.If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result.¿if you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion.After checking the instruction manual for this product, we found the following information.·the knife wire needs to be very thin, so if the length of contact with the duodenal papilla is short, if the high-frequency output is high, if the wire is energized while in contact with the metal part of the endoscope, or if it is stretched too tightly, the knife wire may break.If the knife wire breaks, if force is applied in the direction of tensioning the knife wire, the proximal portion of the cut knife wire will be pulled toward the endoscope, and force will be applied in the direction of pushing the knife wire.If it is, it will be pushed towards the nipple or bounce to the side.If the knife wire breaks, immediately stop energizing it, pull the slider on the operating section completely, pull the cut knife wire into the tube, and then immediately pull out this product from the nipple.A broken knife wire can lead to perforation, major bleeding, laceration of the bile duct, and damage to the endoscope.¿ when inserting or removing this product from the endoscope, pull the slider slightly and move the knife wire along the curve of the tube.If the forceps base of the endoscope is moved back and forth with the knife wire bent, the metal part of the forceps base may come into contact with the knife wire and scrape the coating.- do not apply electricity to a torn or scratched wire sheath while it is in contact with tissue.If a wire coating that is torn or scratched is in contact with tissue and current is applied, the current may leak, resulting in decreased output or unintended tissue burns.¿if you feel that the product is not sharp when energizing, pull out this product from the endoscope and check that there is no damage such as tears or scratches on the wire sheathing." olympus will continue to monitor field performance for this device.
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