BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2150413 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02761
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL; KNIFE WING. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? LUNG. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. DURING WHICH STROKE DID THE EVENT OCCUR? 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? UNK. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNK. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? HIGHER FORCE FOR CLOSING, FIRING AND OPENING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? REP CONFIRMED DEVICE WAS LOADED CORRECTLY. THE ANALYSIS RESULTS FOUND THAT ONE SC60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS WITH THE FIRING MECHANISM JAMMED AND IN THE CLOSE POSITION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO REVIEW THE CONDITIONS OF THE INTERNAL COMPONENTS AND THE ANVIL WAS INDENTED AND ONE WING OF THE KNIFE WAS BROKEN FOUND. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH CLAMPING THE DEVICE OVER AN EXCESS OF TISSUE AND HARD OBJECTS. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT VATS WEDGE RESECTION PROCEDURE, ON THE FIRST FIRING OF THE DEVICE WITH A GREEN CARTRIDGE THE DEVICE WAS DIFFICULT TO FIRE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE CARTRIDGE WAS UNSEATED FROM THE JAWS AND SLIPPING OUT. THE DEVICE WAS RELOADED WITH ANOTHER GREEN CARTRIDGE; IT WAS VERY DIFFICULT TO FIRE. THEY WERE ABLE TO PULL THE TRIGGER THREE TIMES BUT THEY HAD TO USE TWO HANDS AND A LOT OF FORCE. UPON REMOVAL OF THE DEVICE, THE CARTRIDGE WAS LOOSE. UPON EXAMINING THE CARTRIDGE IT WAS ALL MANGLED. IT LOOKS AS THOUGH THE KNIFE DID NOT TRAVEL DOWN THE TRACK BUT INTO THE CARTRIDGE ITSELF. ANOTHER DEVICE WAS LOADED WITH A GREEN CARTRIDGE. THERE WAS DIFFICULTY IN CLOSING THE DEVICE. UPON INITIALIZING THE FIRING THE SURGEON WAS ONLY ABLE TO PULL A 1/2 STROKE. THEY WERE HAVING THE SAME ISSUE. THE SURGEON BACKED OUT OF THE FIRING AND ATTEMPTED TO REVERSE THE KNIFE BLADE. UPON REVERSING THE KNIFE BLADE, THE DEVICE LOCK AND WOULD NOT LET GO. THEY COULD NOT GET THE KNIFE BLADE TO COME BACK TO THE HOME POSITION. THEY CONTINUED TO MANIPULATE THE DEVICE AND FINALLY THE CARTRIDGE BECAME UNSEATED FROM GUN. THIS OPENED ENOUGH SPACE TO BACK THE DEVICE OFF THE TISSUE. HOWEVER THE DEVICE WAS STILL LOCKED. THEY OPENED AN ENDO GIA ULTRA LOADED WITH A BLACK CARTRIDGE, FIRED IT AND EVERYTHING WENT FINE. UPON EXAMINING THE STAPLE LINE THEY FOUND A PIECE OF THE CARTRIDGE FROM ONE OF THE DEVICES IN THE STAPLE LINE. IT WAS RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE; THE CASE WAS DELAYED BY FIFTEEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G