BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP

    MDR report key: 1910214 · Received November 22, 2010

    Report

    Report Number
    2647580-2010-00918
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE STAPLER MISFIRED AND NO TISSUE DONUTS WERE FOUND AFTER FIRING. THE STAPLES WERE MALFORMED AND THE SURGEON HAD TO SUTURE THE ANASTOMOSIS. SURGICAL TIME WAS EXTENDED MORE THAN THIRTY MINUTES DUE TO THE INSTRUMENT NOT FIRING CORRECTLY. ADD'L BLOOD LOSS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP DISPOSABLE STAPLER GDW USSC PUERTO RICO P5M828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other