BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 3090120 · Received May 2, 2013

    Report

    Report Number
    3005075853-2013-02102
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 3, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH TWO ECR60G CARTRIDGE RELOADS PRESENT . THE CARTRIDGE RELOADS WERE 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. THE RETURNED DEVICE AND CARTRIDGE RELOADS 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: DID THE DEVICE CUT? THE KNIFE BLADE APPEAR DEPLOYED AS THERE WAS SLIGHT OOZING ON THE TISSUE. DID THE DEVICE STAPLE? NO STAPLES APPEARED TO FORM. DURING THE OPERATION, WHAT WAS THE APPEARANCE OF THE STAPLE LINE (INTACT, MALFORMED STAPLE, ETC)? NON EXISTENT. WAS THE DEVICE DIFFICULT TO FIRE, BUT FIRED WITH A COMPLETE CUT LINE AND STAPLE LINE WITH THE STAPLES IN THE PROPER B FORM SHAPE? SURGEON CLOSED THE STAPLER WITHOUT ISSUE, THEN COMMENCED THE FIRING SEQUENCE BUT WAS UNABLE TO COMPLETE THE FIRST CLOSURE OF THE TRIGGER (PLASTIC TO PLASTIC) SO USED THE KNIFE BLADE RETURN BUTTON TO RELEASE FROM THE TISSUE. HE ONLY MANAGED TO SQUEEZE A QUARTER OF THE HANDLE CLOSED. DID THE DEVICE CUT? THE KNIFE BLADE APPEARED DEPLOYED AS THERE WAS SLIGHT OOZING ON THE TISSUE. DID THE DEVICE STAPLE? NO STAPLES APPEARED TO FORM. ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? FIRST FIRING PYLORIC ANTRUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? IST. DURING WHICH STROKE DID THE EVENT OCCUR? FIRST. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNLIKELY. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? FIRST. WHAT COLOUR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOUR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? FIRST CARTRIDGE USED. GREEN FIRST AND THEN NEXT FIRING. WAS BUTTRESSING MATERIAL UTILIZED? NONE. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE SURGEON CLOSED THE HANDLE, WENT TO FIRE AND THE FIRING HANDLE JAMMED. SURGEON WAS UNABLE TO COMPLETE THE FIRING SEQUENCE. THE SURGEON REVERSED THE BLADE AND REMOVED THE STAPLER FROM THE CASE. THE STAFF RELOADED A NEW RELOAD, THE SURGEON ATTEMPTED FIRING AGAIN AND THE ERROR REPEATED. THE STAFF OPENED A NEW STAPLER TO COMPLETE THE CASE. NO DELAY TO PROCEDURE. NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192163 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CR7V

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G