BEUDAMED
    FDA Adverse Event Other Summary report: N

    EGIAUSTND

    MDR report key: 2892693 · Received December 21, 2012

    Report

    Report Number
    MW5028352
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 21, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAND ASSISTED LAP NEPHRECTOMY PERFORMED FOR A RENAL CELL MASS. SURGEON REPORTS THAT THE STAPLER MISFIRED AND THE RENAL ARTERY WAS SEVERED. REPAIR DONE INTRAOPERATIVELY BUT PT HAD TO RETURN TO SURGERY. PT HAD 2 ADD'L SURGERIES AND DEVELOPED ISCHEMIC BOWEL AND DIED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIAUSTND STAPLER GDW COVIDIEN N2J02604MX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR