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

Model Number	KD-VC631Q-07203S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an endoscopic retrograde cholangiopancreatography (ercp), the single use preloaded sphincterotome wire broke and fell into the patient¿s pancreatic duct.The surgeon attempted to retrieve the broken wire with grasping forceps but was unsuccessful.The patient returned for an additional procedure to try to remove the piece of broken wire, however that was again unsuccessful.A follow-up is scheduled to discuss possible surgery.
Event or Problem Description
No additional information was received from the customer.This supplemental is being submitted to correct coding.Updates to b2 and f10.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS VIETNAM CO. LTD.; 8 street, long thanh ind. zone; an phuoc commune; dong nai province 81000 0; VM 810000
• MDR Report Key: 23354542
• Report Number: 2429304-2025-00281
• Device Sequence Number: 18442114
• Product Code: KNS
• UDI-Device Identifier: 04953170399503
• UDI-Public: 04953170399503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026
• Report Date (Section F): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-VC631Q-07203S
• Device Lot Number: 4ZK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2026
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/05/2026