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

Model Number	KD-V411M-0730
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the single use 3-lumen sphincterotome v the cutting wire of the papillotome broke or was damaged when cutting under tension.The reported malfunction occurred during a therapeutic endoscopic retrograde cholangio-pancreatography.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
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.Based on the results of the investigation, it was determined that the cutting wire was broken at proximal end site.It's likely the coating portion peeled off because the cutting wire was moved back and forth while the coated portion was in contact with the distal metal part of endoscope.Furthermore, probable causes of the broken cutting wire include: 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.A definitive root cause of the reportable malfunctions could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of 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: 21338732
• Report Number: 9614641-2025-00133
• Device Sequence Number: 18280246
• Product Code: KNS
• UDI-Device Identifier: 04953170184055
• UDI-Public: 04953170184055
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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-0730
• Device Lot Number: 3YV28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 02/07/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown