BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 1933000 · Received December 10, 2010

    Report

    Report Number
    1219930-2010-00942
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THE STAPLER (BLUE CARTRIDGE) WAS FIRED OVER THE WEDGE OF THE LUNG TISSUE. THE STAPLER DID NOT FORM B SHAPED STAPLES. THE SECOND CARTRIDGE WAS OPENED AND FIRED. AGAIN, THE STAPLES DID NOT FORM BS. THERE WAS SOME BLEEDING FOLLOWING THE SECOND STAPLING BUT LESS THAN 250CC. THE CHEST WAS OPENED TO RESOLVE BLEEDING, CONVERTED TO A RIGHT THORACOTOMY UPPER LOBE WEDGE. THE AREA REQUIRED OVER SEWING WITH A CHROMIC SUTURE. THE WEDGE RESECTION OF THE LUNG WAS COMPLETED. THE PT STATUS WAS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA INSTRUMENT DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention