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

Patient Problem Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

Event 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)
• Type of Device: 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
• MDR Text Key: 340137379
• Report Number: 19104395
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 14953170399500
• UDI-Public: (01)14953170399500
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 03/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White