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	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 3-lumen sphincterotome v knife tip portion broke off during energization.The reported issue occurred during endoscopic retrograde cholangiopancreatography (ercp) diagnostic procedure.The procedure was completed using similar device.There was no report of patient harm or user injury associated with this event.
Additional Manufacturer Narrative
The device evaluation and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.A definitive root cause could not be identified.Based on the investigation result, a likely mechanism causing the cutting wire breakage might be the following.1.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.2.Under circumstances described above 1, 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.A likely factor causing tears of the coated portion of the cutting wire might be the following.However, the exact cause could not be determined.1.It is possible that 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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from 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: 20712183
• Report Number: 9614641-2024-20010
• Device Sequence Number: 9904171
• Product Code: KNS
• UDI-Device Identifier: 04953170380587
• UDI-Public: 04953170380587
• 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): 02/06/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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