BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2033541 · Received March 30, 2011

    Report

    Report Number
    3005075853-2011-01270
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICULATION GEAT TEETH. THE ANALYSIS SHOWED THAT THE ATS45 DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED. THE DEVICE WAS RECEIVED WITHOUT A CARTRIDGE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH TEST RELOADS ON THE THREE ARTICULATED POSITIONS; ON THE LEFT AND CENTER IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. HOWEVER, ON THE RIGHT SIDE THE DEVICE MALFORMED SOME OF THE STAPLES. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE ARTICULATION GEAR TEETH WERE FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE DAMAGE ON THE ARTICULATION GEAR, IT IS POSSIBLE THAT THE DEVICE WAS ARTICULATED BEYOND ITS ARTICULATION STOP RESULTED IN THE INSTRUMENT DAMAGE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE SURGEON WAS IN THE FINAL STAGE OF RESECTING THE SMALL BOWEL WHEN THE ATS45 DEVICE APPEARED TO LOSE ITS CORRECT FUNCTIONING OF THE ARTICULATING RATCHET. WHEN THE RATCHET WAS SWIVELED IT APPEARED NOT TO TURN TO ITS FULL ARTICULATED POSITION TO THE RIGHT. THE SURGEON THEN INVERTED THE DEVICE, ARTICULATED IT TO THE OTHER SIDE AND PROCEEDED TO FIRE THE DEVICE. AT THIS STAGE, THIS WAS THE 9TH STAPLE TO BE FIRED. WHEN THE SURGEON DEPRESSED THE TRIGGER, THERE WAS A CLUNKING SOUND AND THE ARTICULATING JAW OF THE DEVICE APPEARED TO SPRING BACK TO ITS ORIGINAL POSITION. THE RESULT WAS THAT THE SMALL BOWEL WAS SEVERELY TORN. AFTER MUCH MANIPULATION, THE SURGEON WAS ABLE TO CLOSE THE TEAR WITH SUTURES AND LATER DETERMINED THAT THERE WAS NO LEAKING AT THE REPAIR SITE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE THE PROCEDURE WAS PROLONGED 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1