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

Model Number	KD-V411M-0720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.A 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.Under circumstances described above, 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.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 when the subject device first box was opened, the knife was broken, and when the second box was opened, the knife was also broken.The third one was finally used normally.The issue occurred during sedation for an unknown therapeutic procedure.The procedure was complete with an olympus back up device.There were no reports of patient harm.
Event or Problem Description
It was reported when the subject device first box was opened, the knife was broken, and when the second box was opened, the knife was also broken.The third one was finally used normally.The issue occurred during sedation for an unknown therapeutic procedure.The procedure was complete with an olympus back up device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental emdr is being submitted to correct the manufacturing date: 7/1/2024.

• 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: 21274158
• Report Number: 9614641-2025-00098
• Device Sequence Number: 15471756
• Product Code: KNS
• UDI-Device Identifier: 04953170382628
• UDI-Public: 04953170382628
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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-0720
• Device Lot Number: 47V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown