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	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) the tip broke and fell into the patient.The customer did not retrieve the tip.

• 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: 23857424
• Report Number: 2429304-2025-00309
• Device Sequence Number: 10116982
• Product Code: KNS
• UDI-Device Identifier: 04953170399503
• UDI-Public: 04953170399503
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2025
• Report Date (Section F): 12/19/2025

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: 58V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/19/2025