BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 1130464 · Received August 20, 2008

    Report

    Report Number
    2647580-2008-00481
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 31, 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: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER FIRING THE DEVICE, IT WAS NOTICED THAT IT HAD NOT COMPLETELY CUT THE ANTERIOR WALL. THE SURGEON MANUALLY CUT AND SUTURED THE AREA TO COMPLETE THE PROCEDURE. NO BLEEDING OCCURRED, AND NO TISSUE DAMAGE WAS REPORTED. SURGERY TIME WAS EXTENDED THIRTY FIVE MINUTES AS A RESULT. THE PT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE-USS P8A0677J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention