BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAKOTA

    MDR report key: 15300492 · Received August 26, 2022

    Report

    Report Number
    15300492
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    April 21, 2022
    Report Date
    April 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE REMOVING KIDNEY STONES WITH A DAKOTA¿ NITINOL STONE RETRIEVAL DEVICE, PHYSICIAN HAS DIFFICULTY REMOVING STONE AND PULLED HARDER TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164395 DAKOTA DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063905000 28879606

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Unknown