MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the single use 3-lumen sphincterotome knife wire broke during a therapeutic endoscopic sphincterotomy procedure.A similar device was used to complete the operation and there were no health hazards due to this incident.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation and from the information obtained, the reported issue was confirmed.The likely mechanism causing the broken cutting wire might be the following: 1.By raising the forceps base of the endoscope, the knife wire at the part where the wire coating was torn came into contact with the tip of the endoscope.As a result of energizing in the state the knife wire instantly became hot at the contact part, leading to breakage.2.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.However, 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.The suggested event is detectable and preventable by handling device in accordance with the following ifu.This instruction manual contains the following information.(drawing no.Rk2599 revision no.2) 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.As a result of checking the instruction manual of this product, the following was found.Figure number: rk2599 edition 2 since the knife wire needs to be 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 stretched too strongly.When the knife wire is broken, if force is applied in the direction of stretching the knife wire, the hand part of the broken knife wire acts so that it is pulled in the endoscope direction, and if force is applied in the direction of pushing the knife wire, it is pushed out in the nipple direction or bounces sideways.If the knife wire breaks, immediately stop energizing, pull the slider on the control part completely, pull the broken knife wire into the tube, and then pull the product out of the nipple immediately.Broken knife wires can lead to perforation, major bleeding, bile duct laceration, and endoscope damage.When inserting and removing this product from the endoscope, pull the slider slightly and move forward and backward with the knife wire along the tube curvature.If the forceps base of the endoscope is moved forward or backward while the knife wire is 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 coating that has been torn or scratched while it is in contact with the tissue.If the wire coating that has been torn or scratched is energized while it is in contact with the tissue, current may leak and may lead to output loss or unintentional tissue burns.If you feel that the sharpness is poor when energizing, pull this product out of the endoscope and make sure that there is no tear, scratch, or other damage to the wire coating.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20384690
• Report Number: 9614641-2024-01945
• Device Sequence Number: 6651911
• Product Code: KNS
• UDI-Device Identifier: 04953170382635
• UDI-Public: 04953170382635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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-V411M-0725
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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