BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1233946 · Received November 14, 2008

    Report

    Report Number
    2647580-2008-00641
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 27, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP COLON. PT GENDER: UNK. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE, THE WINGNUT WAS ROTATED BUT THE DEVICE COULD NOT BE REMOVED FROM THE ANASTOMOSIS. THE DEVICE WAS THEN PULLED AND REMOVED, BUT A PART OF THE BOWEL WAS TORN. A NEW INSTRUMENT OF DIFFERENT TYPE WAS USED TO COMPLETE THE PROCEDURE. NO BLEEDING WAS REPORTED AND NO FURTHER PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P8E0520J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention