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

Model Number	KD-V431M-0730
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the cutting wire of the device was broken at the proximal end site.There was no report of harm, nor adverse effect associated with this event.It was further observed after the procedure, during inspection of the device, that the coated portion of the cutting wire was torn, and the broken portion was melted at the proximal end.
Additional Manufacturer Narrative
E1: phone number was presented as: (b)(6).The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: ¿the coated portion of the cutting wire was torn, and the broken portion was scorched and melted at proximal end.¿ a root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction of ¿he cutting wire was broken at proximal end site¿: 1) the coated portion was torn.2) the cutting wire was exposed by the tear.3) the exposed wire came in contact with the endoscope.4) the device was energized with high-frequency current while the exposed part of wire was in contact with the endoscope.5) the energization caused an electric discharge, resulting in break of the cutting wire.The condition of the coating being peeled off was presumed to have been due to the following: the cutting wire was moved back and forth while the coated portion was in contact with the distal metal part of endoscope.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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: 21447642
• Report Number: 9614641-2025-00200
• Device Sequence Number: 12552339
• Product Code: KNS
• UDI-Device Identifier: 04953170184192
• UDI-Public: 04953170184192
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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-V431M-0730
• Device Lot Number: 43V 09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/24/2025
• 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