BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1180107 · Received September 29, 2008

    Report

    Report Number
    1219930-2008-00709
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPOT SENT TO FDA ON 09/29/2008.

    Description of Event or Problem · 1

    PROCEDURE: VATS. ACCORDING TO THE REPORTER: ON THE FIRST FIRING, SOME STAPLES DID NOT FORM PROPERLY THOUGH KNIFE BLADE ADVANCED COMPLETELY. THE PROCEDURE WAS CONVERTED TO OPEN AND THE STAPLE LINE WAS SUTURED MANUALLY. SURGEON STARTED THE TUMOR SITE WAS CALCIFIED AND VERY HARD. BLEEDING REPORTED AS BETWEEN 200 AND 500CC. THE MALFORMED STAPLES WERE RETRIEVED FROM THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N7F418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPIRATION DATE 04/30/2012| 030455| ENDO GIA ROTICULATOR 45.3.5 SULU| MANUFACTURE DATE: 04/2007| LOT N7D363M