BEUDAMED
    FDA Adverse Event Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1121463 · Received August 13, 2008

    Report

    Report Number
    1219930-2008-00611
    Date Received
    August 13, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP TOTAL COLECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE NO ABNORMALITIES WERE OBSERVED AND NO LEAKS WERE SEEN AT THE CONCLUSION OF THE SURGERY. IN 2008, THE PT WAS RE-OPERATED DUE TO FREE AIR AND LEAKAGE OBSERVED WITHIN THE ABDOMINAL CAVITY. A BUBBLE TEST WAS PERFORMED AT THE BEGINNING OF RE-OPERATION AND A LEAK AS FOUND AT THE RECTAL ANASTOMOSIS. THE SURGEON PERFORMED A WASHOUT AND A TEMPORARY OSTOMY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R