BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1002020 · Received February 22, 2008

    Report

    Report Number
    1219930-2008-00164
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    December 15, 2007
    Report Date
    January 29, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE: LAP COLON. PATIENT SEX: UNK. ACCORDING TO THE REPORTER: THE INSTRUMENT WAS USED WITH A NEW CARTRIDGE WHICH WAS USED TO TRANSECT THE SIGMOID. NO THICKENED TISSUE PRESENT IN THE OPENING OF THE CARTRIDGE. THE SURGEON OPENED THE INSTRUMENT, AND FOUND THAT NO STAPLES WERE FORMED. SOME BLEEDING OF LESS THAN 250CC OCCURRED. ANOTHER INSTRUMENT WAS USED, BUT THE SAME HAPPENED AGAIN. THE SURGEON THEN CHANGED TO A LAPAROTOMY OPEN PROCEDURE, AND THE SURGERY WAS EXTENDED BY 1 HOUR AND COMPLETED. THE PATIENT CONDITION IS UNK, BUT THE PT HAS BEEN RELEASED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS N7H421

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention ENDO GIA ROTICULATOR 45-3.5| PRODUCT ID#: 030455