BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3000013 · Received March 12, 2013

    Report

    Report Number
    3005075853-2013-01206
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 18, 2013
    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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? IT WAS SUPPOSED TO BE USED IN A SIGMOID COLON, BUT THEY DIDN'T GET TO THAT STEP BECAUSE THEY COULDN'T OPEN THE JAW ALREADY ON THE FIRST FIRING. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS?THEY DIDN'T GET TO THE STEP OF PLACING TISSUE IN THE JAW AND FIRING ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? BEFORE THE FIRST FIRING. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? BEFORE OPENING THE JAWS TO PLACE TISSUE IN IT, THAT MEANS AFTER INSERTING THE ECHELON THROUGH THE TROCAR. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE CARTRIDGE WAS LOADED. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? IN THAT DEVICE THEY TRIED ONLY WITH THE BLUE. AND IT WASN'T FIRED EVENTUALLY. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NONE. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO- DIDN'T GET TO THE FIRING STEP. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? 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? AFTER THE COULDN'T OPEN IT, THEY TOOK IT OUT, TRIED TO OPEN IT BY FIRST SWITCHING THE KNIFE DIRECTION AND FIRING AND IT DIDN'T OPEN. THEN THEY TRIED WITH HIGHER FORCE AND IT OPENED EVENTUALLY. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? THERE WAS NO TISSUE INSIDE THE JAW, CAUSE THEY COULDN'T OPEN IT. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE DEVICE WAS SWITCHED BY ANOTHER OF THE SAME KIND AND WORKED FINE THE DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60B CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE AFTER CLOSING THE ECHELON WITH THE BLUE RELOAD AND INSERTING IT THROUGH THE TROCAR THE DOCTOR COULDN'T OPEN IT IN ORDER TO PLACE TISSUE IN THE JAW. THERE WAS A LOCK SIGN ON THE STROKE INDICATOR WINDOW, HE TRIED REVERSING THE KNIFE AND STILL DIDN'T OPEN. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. PROLONGED 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102971 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4AY0J

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B