BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1053140 · Received May 20, 2008

    Report

    Report Number
    1527736-2008-03210
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/20/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY, THE DEVICE WAS FIRED WITH NO CARTRIDGE PRESENT. THE KNIFE MOVED FORWARD AND THE RENAL ARTERY AND VEIN WERE CUT AND THE CASE WAS CONVERTED TO OPEN. THE DEVICE DID NOT LOCK OUT WHEN THE CARTRIDGE WAS NOT LOADED. THE PATIENT LOST AN UNKNOWN AMOUNT OF BLOOD, BUT HAS RECEIVED SIX UNITS RBCS AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JX9V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention