MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE PRELOADED SPHINCTEROTOME

Model Number	KD-VC411Q-0720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during an endoscopic thoracic sympathectomy (est) case, the knife wire broke during the second incision.The procedure was completed by replacing it with another equivalent product, and no health damage occurred.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was returned to olympus for evaluation.The knife wire was confirmed to be broken, and the broken portion was charred and melted.In a survey conducted in the past, the damage to the wire coating was reproduced by the heat generated by the discharge, but the shape of the actual wire coating was similar to the shape of the wire cladding in the reproduction study.In investigation performed in the past, a coated portion damage was duplicated by heat generation due to an electrical discharge.Shape of the coated portion of the subject device was similar to the shape confirmed in the past investigation result.When the outer diameter of the knife wire was measured, there was no abnormality.It was confirmed that there were no problems with the length of the knife wire and wire sheathing, and that there were no defects in the actual product.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The length of the coated portion of the cutting wire, and the cutting wire itself presented no abnormalities.There were no missing parts in the subject device.In addition, no abnormalities that could lead to knife wire breakage were confirmed.Other abnormalities that could lead to the breakage of the cutting wire were not confirmed.Based on the actual product confirmation results and past survey results, it is likely that the knife wire broke due to the following mechanism: the device did not protrude from the endoscope until the rear end of the knife wire entered the field of view.The knife wire was in close proximity to the endoscope tip by: since the power was energized in the state of , a discharge occurred between the knife wire and the tip of the endoscope.The knife wire became momentarily hot and broke due to discharge.Based on the results of confirmation of the device and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following: the device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.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.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That might have caused the cutting wire to break.In addition, we presume that the damage to the wire jacket is caused by the heat at the time of discharge.It can be inferred that heat generated by an electrical discharge caused damage of the coated portion.The event can be detected/prevented by following the instructions for use which state: since the knife wire is very thin, the knife wire may break if the contact length with the duodenal papilla is short, if the high-frequency output is high, if it is energized while in contact with the metal part of the endoscope, or if it is too strong.When the knife wire breaks, if force is applied in the direction of stretching the knife wire, the hand part of the cut knife wire acts so that it is pulled in the endoscopic direction, and if force is applied in the direction of pushing the knife wire, it acts as if it is pushed out or bounces sideways in the nipple direction.If the knife wire breaks, immediately stop energizing, pull the slider of the control part completely, pull the broken knife wire into the tube, and then immediately pull this product out of the nipple.A broken knife wire can lead to perforation, major bleeding, tearing of the bile ducts 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 tube curvature.If the forceps base of the endoscope is moved forward with the knife wire deflected, the metal part of the forceps base may come into contact with the knife wire and scrape the coating.Do not energize the wire sheathing that has been torn or scratched while it is in contact with the tissue.If a torn or scratched wire sheathing is energized while it is in contact with the tissue, current may leak, which may lead to output loss or unintentional tissue burns.When energizing, make sure that the rear end of the knife wire is within the field of view of the endoscope.If the forceps base is energized while the knife wire is in contact, current may leak, resulting in reduced output or unintentional tissue burns.·if you feel that the sharpness is poor when energizing, pull this product out of the endoscope and check that there is no tearing, scratches, or other damage to the wire covering.When energizing, do not use anything other than the incision mode (incision, mixing).Using solidification mode may burn out the knife wire.Do not energize the metal part at the tip of the endoscope and the knife wire in contact or close proximity.Doing so may result in tissue burns, etc., or damage to the endoscope or this product.This instruction manual contains the following information: 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.Do not activate output while the torn or damaged coated portion is in contact with the forceps elevator.Such activation could break the cutting wire at the tear or damage of the coated portion.It may also cause the coated portion to drop into the body.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 activating output, set the output mode of the electrosurgical unit to ¿cut¿ or ¿blend¿.Activating output in the ¿coagulation¿ mode could break the cutting wire.Do not activate output when the distal end of the endoscope is too close to or in contact with body cavity tissue.This could burn the tissue and/or damage the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aormori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15848773
• Report Number: 9614641-2022-00661
• Device Sequence Number: 12374458
• Product Code: KNS
• UDI-Device Identifier: 04953170399312
• UDI-Public: 04953170399312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-VC411Q-0720
• Device Lot Number: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown