BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 45 MM

    MDR report key: 3102905 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02197
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? KIDNEY. AT WHAT LOCATION ON THE TISSUE? RENAL ARTERY. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 1ST. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A WHITE RELOAD LOADED IN THE DEVICE. UPON EVALUATION, THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE CARTRIDGE DECK DAMAGED. THE RELOAD WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE ONE PIECE SLED WAS FOUND DAMAGED. THE DAMAGE TO THE CARTRIDGE 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, THIS IS THE REASON WHY THE SLED GETS DAMAGED. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE ONE PIECE SLED CAN BREAK THROUGH THE CARTRIDGE RELOAD WALL ALLOWING THE FIRING TO CONTINUE. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS 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. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY THE SURGEON BEGAN TO FIRE DEVICE AND IT JAMMED AND WOULD NOT FIRE. THEY MANUALLY REMOVED THE DEVICE BY PUSHING THE RELEASE BUTTON;BLEEDING OCCURRED. THEY USED CLAMPS TO CONTROL THE BLEEDING AND COMPLETED THE PROCEDURE WITH AND ETS45 DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203954 ECHELON*FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 45 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECRW45