BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 3001338 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00176
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: WEDGE RESECTION. ACCORDING TO THE REPORTER: FIRST MAGAZINE DID NOT COMPLETELY CLOSE, BUT DID CUT ENOUGH. SECOND MAGAZINE DID CUT BUT DID NOT STAPLE. PRESSURE PLATE OF BOTH MAGAZINES WERE BENT TO THE SIDE. BLOOD VESSEL WAS DAMAGED AND THERE WAS A STRONG BLEED. THORAX HAD TO BE OPENED FOR STOPPING THE BLEEDING. OPERATION HAD TO BE CHANGED FROM LAPAROSCOPY TO OPEN SURGERY. THE STAPLES FROM THE FIRST DEVICE WERE SHAPED SOMETHING LIKE A B AND NOT PERFECT ONE. STAPLES FROM THE SECOND DEVICE WERE SHAPED LIKE A U AND THE LOADING UNIT DID NOT STAPLE BUT CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95225 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2H0324X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention LOT #: N2G0160LX, MFR DATE 08/2012,| ENDO GIA ROTICULATOR: 030455, 45-3.5 SULU,| EXP DATE 08/31/2017