BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1033851 · Received April 24, 2008

    Report

    Report Number
    2647580-2008-00240
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: KING AND GRIFFIN. DURING ANASTOMOSIS, THE STAPLES WERE APPLIED BUT THE BLADE DID NOT CUT COMPLETELY THE TISSUES SO, THE STAPLER COULD NOT BE REMOVED. THE SURGEON MANUALLY CUT THE TISSUE AND WAS ABLE TO REMOVE THE DEVICE. A LEAK TEST WAS PERFORMED AND NO LEAK WAS OBSERVED. THE SURGEON ELECTED TO PERFORM A TEMPORARY ILEOSTOMY AS A PREVENTATIVE MEASURE. THE PATIENT IS CURRENTLY WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP NONE GDW PONCE - USS P7J1121J

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R