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	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the subject device knife wire was fractured.The issue occurred during preparation for use for a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a corrected to the following field: d4 lot number.
Event or Problem Description
No additional information provided by the customer.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
Updated field(s): h2, h3, h6, h11.Corrected field: h4.The device manufacture date 6/24/24 previously was sent in error should have been 6/5/2024.This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection.Based on the results of the investigation, it was not possible to identify the cause of the incident, however, the most probable cause of the complaint is cause traced to component failure likely due to stress of repeated use, external factors, or handling.Should additional relevant information become available, a supplemental report will be submitted.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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22686276
• Report Number: 9614641-2025-01304
• Device Sequence Number: 9447635
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 46K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 08/18/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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