BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1772152 · Received July 22, 2010

    Report

    Report Number
    1219930-2010-00571
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 22, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE DEVICE FIRED AND THE ANVIL TILTED, HOWEVER, IT WAS DIFFICULT TO REMOVE FROM TISSUE AND THIS CAUSED TENSION ON THE ANASTOMOSIS. THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE TO REMOVE THE INSTRUMENT, WHICH RESULTED IN A DIVERTED ILEOSTOMY. A PORTION OF THE ANASTOMOSIS WAS OPENED DURING DEVICE REMOVAL. THE PATIENT WILL UNDERGO RE-OPERATION IN THE FUTURE. OPERATIVE TIME WAS EXTENDED BY 1.5 HOURS. THERE WAS NO ADDITIONAL TISSUE RESECTED, AND BLOOD LOSS WAS LESS THAN 250CCS. PATIENT IS NOW RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0D0027UH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R