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

Model Number	KD-V411M-0730
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the wire of the single-use 2-lumen sphincterotome was damaged.The issue occurred during a therapeutic procedure and was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction to h6 medical device problem code.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, the reported malfunction was reproduced.The likely mechanism causing the broken cutting wire might be the following: 1.The device was not protruding 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 the 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.It can be inferred that heat generated by an electrical discharge caused damage to the coated portion.The event can be detected and prevented in accordance with the following 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 strongly.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.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.Do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together.This could burn the tissue and/or damage the endoscope or the instrument.After checking the instruction manual for this product, the following was found: digital version: rk2606, edition 02.The knife wire needs to be very thin, so it may break if its contact length with the duodenal papilla is short, if the high-frequency output is high, if electricity is applied while it is in contact with the metal part of the endoscope, or if it is stretched too tightly.If the knife wire breaks, if force is applied in the direction of tensioning the knife wire, the proximal part of the broken knife wire will be pulled toward the endoscope, and if force is applied in the direction of pushing the knife wire, it will be pushed toward the papilla or bounce sideways.If the knife wire breaks, immediately stop applying electricity and pull the slider on the control unit completely to retract the broken knife wire into the tube, and then quickly pull this product out of the papilla.A broken knife wire may lead to perforation, severe bleeding, laceration of the bile duct, and damage to the endoscope.When applying electricity, make sure that the rear end of the knife wire is within the field of view of the endoscope.If electricity is applied while the forceps table and the knife wire are in contact, current leakage may result in a decrease in output and unintended burns to tissue.Do not apply electricity when the metal tip of the endoscope is in contact with or close to the knife wire.This may result in burns to tissue or damage to the endoscope or this product.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of 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: 20242654
• Report Number: 9614641-2024-01844
• Device Sequence Number: 7397754
• Product Code: KNS
• UDI-Device Identifier: 04953170184055
• UDI-Public: 04953170184055
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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-0730
• Device Lot Number: 43V
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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