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

Model Number	KD-V411M-0330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation results, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, drawing from similar investigation results in the past, a possible mechanism for the breakage of the cutting wire may involve the following: 1) the device was energized in one of the following situations.(a) the cutting wire is in point contact with tissue.Or they were being close to each other.(b) the cutting wire is in point contact with the distal end of the endoscope.Or they were being close to each other.2) an electrical discharge occurred in the cutting wire, and the cutting wire became hot instantly.3) the cutting wire was broken.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that the single use 3-lumen sphincterotome v wire broke during use, but there were no reports of patient harm.

• 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: 21437690
• Report Number: 9614641-2025-00190
• Device Sequence Number: 4567459
• Product Code: KNS
• UDI-Device Identifier: 04953170380563
• UDI-Public: 04953170380563
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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-0330
• Device Lot Number: 43V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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