BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1080494 · Received July 22, 2008

    Report

    Report Number
    1219930-2008-00541
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 7, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP TOTAL COLECTOMY. ACCORDING TO THE REPORTER: INTRA-OPERATIVELY THERE WERE NO ABNORMALITIES NOTED, NO LEAKS, AND STAPLE FORMATION WAS PROPER. FOURTEEN DAYS POST-OPERATIVELY THE PT BECAME ILL AND SEPTIC AND WAS RE-OPERATED DUE TO STOOL AND FLUID SEEN IN THE ABDOMEN AND PELVIS. THE SURGEON NOTICED THAT THE STAPLE LINE HAD FALLEN APART. THE PT SUBSEQUENTLY WAS GIVEN A DIVERTING ILEOSTOMY AND WAS ADMITTED TO THE ICU. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S