BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON 5" TRACHEAL HOOK

    MDR report key: 1664171 · Received April 8, 2010

    Report

    Report Number
    1664171
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    April 5, 2010
    Report Date
    April 8, 2010
    Manufacturer
    MSI SURGICAL SOLUTIONS
    Product Code
    KCH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SMALL PIECE OF THE TRACHEAL HOOK RIGHT ANGLE BROKE OFF WHILE TRACH WAS BEING PULLED ON PATIENT WITH RESPIRATORY FAILURE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. THE HOOK AND THE BROKEN PIECE WERE RETURNED TO MSI SURGICAL SOLUTIONS, WHO IS RESPONSIBLE FOR EQUIPMENT ON THE TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON 5" TRACHEAL HOOK RETRACTOR, HOOK KCH MSI SURGICAL SOLUTIONS 514431 FF0

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR