BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 1052811 · Received May 27, 2008

    Report

    Report Number
    1219930-2008-00406
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 05/27/2008

    Description of Event or Problem · 1

    PROCEDURE: PNEUMO-RESECTION. ACCORDING TO THE REPORTER: THE LOADING UNIT BENT WHEN THE STAPLER WAS APPLIED. THE JAWS DID NOT CLOSE CORRECTLY ON TISSUE AND STAPLES WHERE NOT CORRECTLY FORMED. THIS LOADING UNIT WAS CHANGED WITH A NEW ONE WITH THE SAME LOT NUMBER AND APPLIED WITH THE SAME RESULTS. A THIRD LOADING UNIT WAS USED, WITH A DIFFERENT LOT NUMBER, AND THE RESULT WAS OK. THE APPLICATION WAS ON PULMONARY PARENCHYMA. NO INJURIES WERE REPORTED FROM THE PT AT THE END OF SURGERY. AN UNSPECIFIED AMOUNT OF BLEEDING OCCURRED. SURGERY TIME WAS EXTENDED APPROX 40 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8A164

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 030449| LOT N7G99| MFR DATE 07/2007