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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.Based on the results of the investigation, a root cause could not be determined.It is likely the following led to the malfunction: an electric conduction was activated.This may have caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.Additionally, it can be inferred that some kind of force may have been applied to the coated portion of the cutting wire causing the coated portion of the cutting wire to tear/detach from the cutting wire.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the knife wire was fractured.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction is being made to previously submitted g3 - date received by manufacturer, which was not late.The correct date was 21oct2025.Updated field: b5.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information provided: it was reported that the knife wire was fractured upon initial opening of the box (oob) and had not been used by the user.Upon return of the device, the visual inspection concluded that the device had been utilized and energized during an unspecified procedure.There was no report of patient harm.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: h2, h3, h6, h11.The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: 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.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.Olympus will continue to monitor the performance of this device.
Event or Problem Description
No additional information received from the customer.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23777602
• Report Number: 9614641-2025-02044
• Device Sequence Number: 13282829
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 47K31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 01/27/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/28/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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