BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1180045 · Received March 11, 2008

    Report

    Report Number
    1219930-2008-00218
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 19, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LUNG RESECTION. ACCORDING TO THE REPORTER: WHEN FIRING THE FIRST LOAD OVER UPPER LOBE, ALL STAPLE EXCEPT A FEW ON THE PROXIMAL END STAYED THEIR LEGS STRAIGHT. THE INCOMPLETE STAPLE LINE WAS SUTURED MANUALLY. THEN, THE INSTRUMENT WAS FIRED TO RESECT THE BLEB BUT STAPLES WERE MALFORMED. UNDER 200CC BLEEDING OCCURRED, BUT THERE WAS A 30 - 40 MINUTES DELAY IN THE CASE. THE ACCOUNT RETURNED 5 SULUS, BUT IT IS UNCLEAR WHICH OF THEM ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS N7M06

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LOT #: N7M190 OR N7M191| PRODUCT| ENDO GIA ROTICULATOR 60-3.5 SULU