BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 494372 · Received November 7, 2003

    Report

    Report Number
    1219930-2003-00252
    Event Type
    Death
    Date Received
    November 7, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 14, 2003
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECION. REPORTEDLY, DURING THE PROCEDURE, WITH THE SECOND FIRING, THE STAPLES WOULD NOT FORM PROPERLY. WITH THE THIRD FIRING, ALMOST ALL OF THE STAPLES COULD NOT BE FORMED AT ALL. THE FORCE OF SQUEEZING THE HANDLE WAS VERY STIFF. REINFORCED THE RECTUM FRAGMENT BY HAND SEWING. IT WAS CONFIRMED THE ANVIL WAS BENT. ADDITIONAL INFORMATION RECEIVED: "THE PATIENT DIED BECAUSE MOF (MULTI ORGAN FAILURE) FROM RENAL DYSFUNCTION. ACCORDING TO THE SURGEON, THERE IS NO RELATIONSHIP BETWEEN THE STAPLE MALFORMATION AND PATIENT'S DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GAG NORTH HAVEN - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death EXPIRATION DATE UNKNOWN.| LOT NUMBER UNKNOWN.| 030455 - ENDO GIA ROTICULATOR SULU.