BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1850492 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05642
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 16, 2010
    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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT THE (B)(4) DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A (B)(4) CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED (B)(6). 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 CARTRIDGE RELOAD WAS 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS DURING INSERTION OF THE CATHETER, THE CATHETER PULLED OFF OF THE TUNNELER WHILE IN THE TUNNEL TRACT. THE CUSTOMER REPORTS HE REMOVED THE ONE APPLIED CLAMP IN ORDER TO QUICKLY GRASP THE TIP OF THE CATHETER TO PULL IT THROUGH THE TUNNEL TRACT (THUS LEAVING NO CLAMPS ON THE CATHETER). THE CUSTOMER REPORTS HE FEELS THE PT IS AT RISK FOR AIR EMBOLISM DURING THIS MANEUVER OF REMOVING/RELOCATING THE CLAMP. THE CUSTOMER THEN PULLED THE CATHETER BACK AND RE-TUNNELED A LARGER TRACT SO THAT HE COULD PUSH THE CATHETER THROUGH THE TRACT AND NOT HAVE IT DETACH. THE LARGER EXIT SITE WAS THEN SUTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DOCTOR CLOSED THE STAPLER TO ENTER THE PORT. ONCE INSIDE THE PATIENT, THE SURGEON OPENED THE STAPLER AND PLACED THE STAPLER ACROSS THE STOMACH NEAR THE PYLORUS. THE SURGEON CLOSED THE STAPLER, AND WAITED FIFTEEN SECONDS. THE SURGEON THEN PROCEEDED TO FIRE THE STAPLER, HOWEVER THE SAFETY LOCKOUT HAD DEPLOYED AND THE SURGEON WAS UNABLE TO FIRE THE STAPLER. THE SURGEON USED THE RED BUTTON TO REVERSE THE KNIFE BLADE, AND REMOVED THE STAPLER FROM THE PATIENT. THE OBSERVED APPROXIMATELY THREE STAPLES HAD ENTERED THE GASTRIC TISSUE; HOWEVER THE SURGEON WAS ABLE TO REMOVE THESE UNFORMED STAPLES FROM THE TISSUE WITH A GRASPER. THE SURGEON CHANGED TO A NEW STAPLER AND COMPLETED THE CASE WITHOUT FURTHER DELAY. SURGERY WAS PROLONGED THREE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RC0J

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60G