BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60

    MDR report key: 1963752 · Received January 19, 2011

    Report

    Report Number
    1527736-2011-00020
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. BUCKED KNIFE THE ANALYSIS RESULTS FOUND THAT ONE EC60A DEVICE WAS RETURNED WITH THE ANVIL DAMAGED AND CLOSED, THE FIRING MECHANISM JAMMED AND WITH A PARTIALLY FIRED CARTRIDGE RELOAD LOADED ON THE DEVICE. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE KNIFE HAD BUCKLED, AND CARTRIDGE RELOAD WAS INDENTED. THE DAMAGE TO THE CARTRIDGE, KNIFE AND ANVIL IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER, THE KNIFE WILL BUCK, AND AS THE KNIFE IS ATTEMPTING TO PULL THE ANVIL TOWARDS THE CARTRIDGE TO FORM THE STAPLES, IT WILL RESULT IN THE DAMAGE OBSERVED ON THE ANVIL. WHEN THE KNIFE BUCKLES, THE FIRING MECHANISM BECOMES JAMMED UNABLE TO RETURN THE KNIFE COMPLETELY AND BEING ABLE TO OPEN THE DEVICE. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION ARE INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO ASSISTED THORACIC SURGERY WITH PNEUMONECTOMY PROCEDURE, THE DEVICE WAS PLACED ACROSS LUNG TISSUE. ON THE FIRST FIRING, THE FIRST TWO STROKES SEEMED TO GO OKAY, THE THIRD STROKE COULD NOT BE COMPLETED. THEY HIT THE RED MANUAL RETURN BUTTON AND PULLED THE FIRING HANDLE IN AN ATTEMPT TO RETURN THE KNIFE BLADE: BUT IT WAS TOTALLY STUCK. THEY WERE ABLE TO MOVE THE KNIFE BLADE A THIRD OF WAY BACK, THEN IT STUCK. THEY COULD NOT GET IT ALL THE WAY BACK TO OPEN IT AND COULD NOT REMOVE DEVICE OFF THE LUNG TISSUE. AS THE BLADE WAS COMING BACK YOU COULD SEE A THIN STRIP OF PLASTIC BEING CUT AWAY FROM THE CARTRIDGE RELOAD. NO PIECES FELL IN TO THE PATIENT. A NEW ECHELON WAS USED TO STAPLE INFERIOR TO WHERE THE FIRST STAPLER WAS STUCK. THERE WAS EXCESSIVE BLEEDING, THE PATIENT LOSS APPROXIMATELY 3000CC BLOOD AND HAD TO HAVE A TRANSFUSION. THE PATIENT WAS STABLE LEAVING THE OPERATING ROOM. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention