BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 1964092 · Received January 11, 2011

    Report

    Report Number
    1219930-2011-00017
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 7, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SURGEON USED TWO FIRINGS OF 45MM FOR THE LOWER RECTUM. THE FIRST FIRING, THE STAPLE LINE WAS FINE BUT NEEDED TO BE COMPLETED WITH A SECOND FIRING. WHEN FIRING THE SECOND 45MM BLUE SULU, THE KNIFE CUT BUT SURGEON SAYS THERE WAS NO STAPLES. THE SURGEON REALIZED ONLY WHEN THEY TRIED INTRODUCING THE CEEA AND SAW THAT NO STAPLES HAD BEEN FIRED AND THAT THE STAPLE LINE WAS NOT COMPLETE. SHE HAD TO RESORT TO AN OPEN PROCEDURE WHICH TOOK AN EXTRA 3 HOURS. THE PT IS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0H0615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention