BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1810131 · Received August 17, 2010

    Report

    Report Number
    2647580-2010-00713
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: COLON RESECTION. ACCORDING TO THE REPORTER: AT THE TOTAL MESORECTAL EXCISION AN ULTRA DEEP ANASTOMOSIS WAS NECESSARY. THE PRESSURE PLATE WAS INTRODUCED LIKE USUALLY AND THE INSTRUMENT WAS INTRODUCED RECTAL AND CONNECTED WITH THE PRESSURE PLATE. THE SURGEON FIRED THE INSTRUMENT, FOUR HALF TURNS AND THE INSTRUMENT WAS UNABLE TO BE REMOVED. IT HAD TO BE CUT MANUALLY CIRCULAR OUT WITH SCISSOR AND OVER SEWED. A NEW ANASTOMOSIS WAS NOT NECESSARY. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES. NO ADDITIONAL BLOOD LOSS, NO EXTENSION OF THE INCISION, NO CHANGE OF OP, NO LOSS OR DAMAGE TO TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P9J0983J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other