BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 21 INST W/O TILT-TOP

    MDR report key: 1810140 · Received August 17, 2010

    Report

    Report Number
    2647580-2010-00716
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: AFTER FIRING, THE DEVICE COULD NOT BE SMOOTHLY REMOVED. IT CAUSED A TEAR IN THE ANASTOMOSIS PORTION. THE STAFF CONVERTED TO OPEN SURGERY AND MANUAL SUTURING WAS DONE. ADDITIONAL BLEEDING WAS OVER 500CC. NOTHING FELL INTO THE PATIENT CAVITY., THERE WAS TISSUE DAMAGED. NO PATIENT INFO AVAILABLE. THE DONUT TISSUE WAS FOUND PROPERLY FORMED, THEREFORE IT SEEMED ANASTOMOSIS WAS DONE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 21 INST W/O TILT-TOP DISPOSABLE STAPLER GDW USSC PUERTO RICO S0AC010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R