BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2133454 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02471
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A WHITE CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOAD 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE DEVICE COULD BE FIRED WITHOUT ANY PROBLEMS AT THE FIRST FIRING. HOWEVER, THERE WAS NO FEEDBACK OF GRASPING THE FIRING TRIGGER AT THE SECOND FIRING AND THE KNIFE DID NOT MOVE FORWARD. BESIDES, THE JAW COULD NOT BE OPENED, SO THE DEVICE WAS REMOVED FROM THE PATIENT BY CUTTING BOTH SIDES OF THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE?---COLON. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS?---NO INFORMATION. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR?---2ND. WHAT COLOR CARTRIDGE WAS BEING USED?---GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT?---GOLD WAS USED AT THE 1ST FIRING. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?---NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---THE FORCE OF FIRING WAS HIGHER. 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? ---ALTHOUGH THE MANUAL KNIFE REVERSE SWITCH WAS PUSHED DOWN AND THE FIRING TRIGGER WAS FULLY GRASPED, THE JAW COULD NOT BE OPENED. IT WAS UNKNOWN WHICH DIRECTION THE KNIFE BLADE INDICATOR WAS. THE DEVICE WAS REMOVED BY CUTTING BOTH SIDES OF THE JAW WITH ANOTHER DEVICE THROUGH THE OTHER TROCAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1