BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2150722 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02777
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 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). THE SC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60G CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED (B)(4). 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 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS LOCKED OUT AT THE FIRST FIRING WHEN IT WAS FIRED ON THE RECTUM. THE SHAFT WAS ARTICULATED. ALTHOUGH THE RELEASE BUTTON WAS PUSHED, THE DEVICE COULD NOT BE RELEASED. THE DEVICE EVENTUALLY COULD BE RELEASED WHEN THE MANUAL KNIFE REVERSE SWITCH WAS PUSHED OR THE FIRING TRIGGER WAS GRASPED SEVERAL TIMES. SOME STAPLES OF THE PROXIMAL PART WERE UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. REINFORCEMENT MATERIAL WAS NOT USED. ADDITIONAL INFORMATION: WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS?---NO INFORMATION. WHAT STROKE DID THE EVENT OCCUR? ---1ST. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---THE DEVICE WAS NOT USED BEFORE AND AFTER THIS EVENT. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ---NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO INFORMATION. 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? ---NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43J31

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G, (B)(4)