MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED); UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	KD-VC631Q-07203S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Clever cut 3v used during ercp (endoscopic retrograde cholangiopancreatography), at the time of the sphincterotomy during the bowing, the wire broke while at the ampulla inside the patient in the scope.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 19104395
• Report Number: 19104395
• Device Sequence Number: 12614376
• Product Code: KNS
• UDI-Device Identifier: 14953170399500
• UDI-Public: (01)14953170399500
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/25/2024
• Report Date (Section F): 03/25/2024

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
• Device Model Number: KD-VC631Q-07203S
• Device Catalogue Number: N5779430
• Device Lot Number: 3XV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White
• Date Report Sent to FDA: 03/25/2024