MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)

Model Number	KD-VC611Q-07303S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the single use preloaded sphincterotome cutting wire snapped.The issue occurred during a therapeutic endoscopic retrograde cholangiopancreatography (ercp)procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: d8, d9, h2, h3, h4, h6, h11.The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.The cutting wire and the endoscope were being close to each other.The output was activated.This had led to an electrical discharge between the cutting wire and the distal end of the endoscope.An electrical discharge occurred, and the cutting wire became hot instantly.This had caused the cutting wire to break.Olympus will continue to monitor the performance of this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED 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: 23037767
• Report Number: 9614641-2025-01522
• Device Sequence Number: 21367967
• Product Code: KNS
• UDI-Device Identifier: 04953170399442
• UDI-Public: 04953170399442
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141991
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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-VC611Q-07303S
• Device Lot Number: 47V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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