BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 2140264 · Received June 15, 2011

    Report

    Report Number
    1219930-2011-00506
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 9, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    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 TYPE: LAPARATOMY WITH FOLLOWING SUBTOTAL HEMICOLECTOMY. ACCORDING TO THE REPORTER: AT THE DISPLACE OF THE DISTAL SIGMA THE CLIP ROW OF THE DEVICE MALFUNCTIONS. THE DEVICE WAS LOADED AND RELEASED/FIRED CORRECTLY. THE INTESTINE WAS CUT, BUT THE CLIPS FELL NEARLY COMPLETELY INTO THE SITUS. BY THE NEXT TRIAL SAME RESOLUTION. WE CHANGED THE INSTRUMENT/HANDLE AND USED THE SAME MAGAZINE WITH THE SAME LOT - AGAIN THERE WAS NO CLIP SEAM. THEN WE USED A MAGAZINE WITH ANOTHER LOT (15MM, 45-4.8). PROCEDURE WAS THEN SUCCESSFUL. THE CLIPS THAT FELL HAD TO BE RETRIEVED MANUALLY. ACCORDING TO THE REPORTER, THE PATIENT WAS INJURED DUE TO THE DEVICE FAILURE. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES. NO UNANTICIPATED BLOOD LOSS OCCURRED. THERE WAS NO EXTENSION OF THE INCISION. NO TISSUE DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0M0637L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other