BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE

    MDR report key: 3802290 · Received April 29, 2014

    Report

    Report Number
    3802290
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE THE COOK NGAGE NITINOL STONE EXTRACTOR WAS USED ONE TIME AND THE DEVICE BROKE WITH A WIRE STICKING OUT. THE CASE WAS DELAYED TO OBTAIN A NEW STONE EXTRACTOR. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255532 NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK, INC. * U2453113

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR