BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA¿ ULTRA UNIVERSAL STAPLER

    MDR report key: 2935436 · Received December 26, 2012

    Report

    Report Number
    2935436
    Event Type
    Death
    Date Received
    December 26, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FOR LAP NEPHRECTOMY. ENCOUNTERED BLEEDING PROBLEMS AFTER STAPLING RENAL ARTERY. UNABLE TO CONTROL BLEEDING, CONVERTED TO OPEN, VASCULAR SURGERY CALLED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA¿ ULTRA UNIVERSAL STAPLER STAPLER, SURGICAL GDW COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE NEXT GENERATION STANDARD HANDLE N2JO392UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death