BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONETM

    MDR report key: 17949529 · Received October 17, 2023

    Report

    Report Number
    17949529
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 19, 2023
    Manufacturer
    COVIDIEN LP
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MED TRONIC ATHRECTOMY DEVICE HWK M MALFUNCTIONED WHILE DOING AN ATHRECTOMY ON A LEFT LOWER LEG EXTREMITY. CUTTER BLADE WOULD NOT ENGAGE BACK INTO ITS HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93524 HAWKONETM CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN LP H1-14550 0011598690

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Male