BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE

    MDR report key: 15645305 · Received October 21, 2022

    Report

    Report Number
    15645305
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 5, 2022
    Manufacturer
    COOK INCORPORATED
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INNER STIFFENER BROKE OFF WHILE TRYING TO PLACE NU STENT IN PATIENT. STIFFENER STRETCHED AND SNAPPED CAUSING FAILURE OF THE DEVICE. THE DEVICE HAD TO BE REMOVED AND ANOTHER NU TUBE WAS ATTEMPTED (SAME BRAND AND TUBE SIZE). THE SAME THING HAPPED WHILE TRYING TO PLACE THE SECOND ONE. AFTER THE SECOND FAILURE THE PROCEDURE WAS ALTERED, AND A REGULAR NEPHROSTOMY WAS PLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2630322 COPE STENT, URETERAL FAD COOK INCORPORATED G48183 14330551

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Male