BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE

    MDR report key: 3121659 · Received April 30, 2013

    Report

    Report Number
    3121659
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    COOK MEDICAL
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE WIRES ON THE BASKET ARE FRAYED AND BROKEN. THEY WERE NOT ABLE TO GRAB THE STONES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PERCUTANEOUS LITHOTRIPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187875 NGAGE DISLODGER, STONE, BASKET FFL COOK MEDICAL G48295 U2310317

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR