BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUIM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1083289 · Received July 28, 2008

    Report

    Report Number
    2647580-2008-00434
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 10, 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: COLORECTAL ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE, IT WAS NOTED THAT A PART OF THE ANVIL WAS NOT COMPLETELY CLOSED. THERE WERE NO ABNORMALITIES WITH THE APPLICATION, HOWEVER, THE SURGEON PERFORMED A PRECAUTIONARY ILEOSTOMY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUIM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P6M430J

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R