Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.A visual inspection of the received condition of the device was performed.The cutting wire was observed to be broken.The cutting wire is split near the distal end side with missing pieces, which are not returned for evaluation.The device was not returned in the original package.The handle section appears normal.The slider manipulates, the plug, guidewire port, hook, connector, joint, and injection port appear normal.The labeling on the handle section is normal, and the lot number is present.The tube section of the insertion portion has two kinks near the middle.The distal end section of the device is missing the pre-curved stylet, which was not returned for evaluation.As noted earlier, the cutting wire is broken, with thermal damage (charring) on the distal end portion of the wire.The coated portion of the cutting wire is also missing.The proximal and distal markers are visible.A functional inspection could not be performed due to the condition of the cutting wire.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported device problem.A review of the device history record found no deviations that could have caused or contributed to the reported problem.The device was shipped in accordance with the specifications.A definitive root cause for the reported problem was not established.While the reported device problem was not reproduced, it was proposed that the incident occurred according to the following: 1.The cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised.2.The output was activated as described in (1), and the cutting wire became hot instantly.This caused the cutting wire to break.The tear on the coated portion of the cutting wire was reproduced, however.This was achieved by the following: 1.The forceps elevator of the endoscope was raised.2.When the cutting wire deflected, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.3.Per (2)¿, the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.The slider was pushed excessively, this caused the cutting wire to deflect.Based on the above, it was inferred that a force may have been applied to the coated portion of the cutting wire when the device was withdrawn from the endoscope (after the coated portion of the cutting wire was torn).This in turn, may have caused the coated portion of the cutting wire to detach from the cutting wire, hence the partially missing coated portion.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following¿ ¿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.Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.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.¿ olympus will continue to monitor field performance for this device.
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