BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3170305 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03021
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60D CARTRIDGE RELOAD PRESENT. 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 BEEN 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 STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. AS ONE PREFORMED STAPLE WAS OUT OF THE CARTRIDGE POCKET, ONE STAPLE WAS MISSING ALONG THE STAPLE LINE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE TISSUE CUT? ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOW ANTERIOR RESECTION, THE DEVICE COULD NOT BE FIRED AT THE 1ST STROKE OF THE 1ST FIRING AFTER CLOSING. THE LOCKOUT SYMBOL WAS SHOWN. THE DEVICE WAS RELEASED WITH THE MANUAL KNIFE REVERSE SWITCH, AND AFTER THE JAWS WERE OPENED, IT WAS FOUND THAT THE TARGET TISSUE WAS NOT STAPLED AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CARTRIDGE COLOR WAS GOLD. REINFORCEMENT MATERIAL WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271674 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60DX1 (BATCH:K59L7P)