BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1952923 · Received January 7, 2011

    Report

    Report Number
    1527736-2011-00011
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    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 ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60B CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 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 RETURN AND TEST CARTRIDGE WERE LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FELL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. A DVD OF THE PROCEDURE WAS RECEIVED, EVIDENCE FROM THE DVD INDICATING THAT THE CARTRIDGE WAS NOT PROPERLY SEATED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS ADDITIONAL INFORMATION: FIELD QUALITY ENGINEER VIEWED DVD: THE BLUE CARTRIDGE APPEARED TO BE NOT PROPERLY SECURED INTO THE CHANNEL. IMAGES OF THE CARTRIDGE APPEARED TO BE NOT PROPERLY SECURED. IN BOTH CASES ABOVE THERE APPEARED TO BE TO MUCH BLUE PLASTIC ABOVE THE CHANNELS EDGE TO BE PROPERLY SECURED. (NOTE THAT THE ANGLE AND MAGNIFICATION CAN DISTORT WHAT APPEARS IN AN IMAGE). AFTER THE DEVICE WAS FIRED AND REMOVAL WAS ATTEMPTED IT APPEARED AS IF THE DISTAL TIP OF THE CARTRIDGE WAS STUCK ON SOMETHING. IT SHOULD BE NOTED THAT THE STAPLE LINES LOOK GOOD WITH GOOD HEMOSTASIS, HENCE THE CARTRIDGE MAY HAVE BEEN DISLODGED AFTER FIRING BY WHAT EVER WAS GRIPPING THE DISTAL TIP. IT SHOULD ALSO BE NOTED THAT THE CARTRIDGE HAD TO BE PULLED OFF WHAT EVER IT WAS ATTACHED TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROTOMY PROCEDURE, WHEN THE JAW WAS OPENED AFTER THE FIRING, THE CARTRIDGE CAME OFF FROM THE JAW. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS USED ON THE RECTUM DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION. THE EVENT OCCURRED AFTER THE 1ST FIRING. THE TISSUE WAS NOT SO THICK. THE DEVICE WAS NOT FIRED ACROSS OR NEAR THE HARD OBJECTS. REINFORCEMENT MATERIAL WAS NOT USED. WHEN THE CARTRIDGE WAS LOADED INTO THE JAW, THE SNAP SOUND WAS NOT CONFIRMED. THE DEVICE HAD NOT DIFFICULTY IN CLOSING BUT WE HAVE NO DETAILED INFORMATION WHETHER THERE WAS DIFFICULTY IN FIRING OR NOT. THE STAPLES WERE DEPLOYED ON THE TISSUE AND THEY LOOKED LIKE NO PROBLEMS. THE DOCTOR COMMENTED THAT THE JAW SEEMED TO TOUCH THE PUBIS WALL DURING THE OPERATION. THE FALLEN CARTRIDGE WAS RETRIEVED BY A FORCEPS. THE PATIENT IS GETTING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - (B)(4)