BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOHAWK

    MDR report key: 2201256 · Received August 5, 2011

    Report

    Report Number
    2201256
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    April 25, 2011
    Report Date
    August 5, 2011
    Manufacturer
    EV3
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE HOUSING UNIT FAILED TO CLOSE WHILE INSIDE THE VESSEL. THE PATIENT WAS NOT HARMED. A SECOND DEVICE WAS OPENED TO COMPLETE THE PORCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK CUTTING DEVICE MCW EV3 LS-C 9396703

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR OTHER