BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-2.5 SULU

    MDR report key: 2922500 · Received January 14, 2013

    Report

    Report Number
    1219930-2013-00036
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC RADICAL NEPHRECTOMY ACCORDING TO THE REPORTER: AFTER FIRING TWO CARTRIDGES THE SURGEON FIRED THE CARTRIDGE ON THE RENAL VEIN. DURING THE FIRING PROCESS, THE SURGEON NOTICED A MASSIVE BLEEDING FROM THE RENAL VEIN AND HAD TO CONVERT THE LAP PROCEDURE TO AN OPEN PROCEDURE. ACCORDING TO THE SURGEON, AT THE END OF THE PROCEDURE, HE COULDN'T FIND STAPLES ON THE VESSEL. THE 500 CC BLOOD TRANSFUSIONS WAS GIVEN DURING THE PROCEDURE. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20066 ENDO GIA ROTICULATOR 45-2.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other