BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA, UNIVERSAL ROTICULATOR

    MDR report key: 2616298 · Received June 9, 2012

    Report

    Report Number
    2616298
    Event Type
    Malfunction
    Date Received
    June 9, 2012
    Date of Event
    April 16, 2012
    Report Date
    June 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLE LOAD LOADED (COVIDIEN 030451, 30MM, VASCULAR). TESTED WITH OPENING AND CLOSING THE JAWS BEFORE GOING DOWN THE LAPAROSCOPIC PORT. SURGEON OPENED THE JAWS ON THE RENAL VEIN. CLOSED THE JAWS AND THE TRIGGER WOULD NOT MOVE. SO A SECOND SIMILAR LOAD WAS TRIED IN THE SAME GUN LIKE HANDPIECE (STAPLER) AND FIRED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA, UNIVERSAL ROTICULATOR STAPLER, RELOAD, SURGICAL GDW COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE 030451 N1M0430LX

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR