BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSTON SPHINCTEROTOME 7F 25MM 175CM

    MDR report key: 22296686 · Received June 20, 2025

    Report

    Report Number
    MW5171608
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Report Date
    May 6, 2025
    Manufacturer
    COOK INCORPORATED
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ON MARCH 21, 2025, ABOUT AN EVENT REGARDING THE USE OF TWO FUSTON SPHINCTEROTOME 7F 25MM 175CM COMPATIBLE 0.035 REF: G3 1903, REF: FSOMNL (MAGH2 REF: 404890): 1ST BATCH: W4906396, EXPIRY DATE: JANUARY 20, 2028 - INTERNAL MATERIOVIGILANCE REGISTRATION NUMBER: 2025-A027. 2ND BATCH: W4872641, EXPIRY DATE: SEPTEMBER 23, 2027 - INTERNAL MATERIOVIGILANCE REGISTRATION NUMBER: 2025-A028. THIS IS NOT A DEVICE MANUFACTURED BY (B)(6). IT WAS REPORTED THAT THE CUTTING WIRE BROKE DURING THE SPHINCTEROTOMY. PATIENT'S ANATOMY: NOTHING TO REPORT. NO STRAIN ON THE ENDOSCOPE OR THE SPHINCTEROTOME. LONG POSITION RELATIVE TO THE PAPILLA. THE CUTTING WIRE BROKE AFTER TWO USES OF THE ELECTROCAUTERY. TWO SPHINCTEROTOMY DEVICES WERE USED, SAME PROBLEM FOR BOTH. WE USED A SPHINCTEROTOMY DEVICE FROM ANOTHER LAB. REFERENCE REPORT MW5171609. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089380 FUSTON SPHINCTEROTOME 7F 25MM 175CM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown