BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-4.8 SULU

    MDR report key: 1040586 · Received May 9, 2008

    Report

    Report Number
    1219930-2008-00359
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON PERFORMED A LAPAROSCOPIC RIGHT COLECTOMY IN 2008. INTRAOPERATIVELY, THE ANASTOMOSIS APPEARED TO BE INTACT. TEN DAYS POSTOPERATIVELY A CAT SCAN REVEALED THE PATIENT HAD FREE AIR AND FREE FLUID IN HIS ABDOMEN. THE SURGEON REOPERATED AND FOUND AN OPENING IN THE ANASTOMOSIS WHICH WAS LEAKING. THE STAPLES APPEARED TO BE FOUND FORMED CORRECTLY. THE PATIENT BROUGHT BACK TO THE OR FOR A DIVERTING COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-4.8 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention