BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 3030147 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01534
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED WITH A COMPETITIVE TROCAR ON THE SHAFT, THE CLOSING TRIGGER AND ANVIL WERE IN THE CLOSED POSITION, AND THE FIRING MECHANISM IN THE RETURN STROKE WITH THE KNIFE NOT FULLY BACK. ONE ECR60G CARTRIDGE RELOAD WAS LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. IN ADDITION, THE SHROUDS WERE SLIGHTLY SEPARATED IN THE REGION OF THE STROKE INDICATOR. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. A CT SCAN WAS PERFORMED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE KNIFE LOCKOUT TAIL WAS NOTED TO BE BENT PROBABLY DUE TO THE INTERACTION WITH A FOREIGN TOOL PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. PLEASE NOTE THAT TO DISARTICULATE THE DEVICE, IT MUST BE IN THE OPENING POSITION. 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

    Additional Manufacturer Narrative · 1

    (B)(4). VIDEO ANALYSIS AN INTRA OPERATIVE VIDEO WAS RECEIVED. UPON REVIEW OF THE VIDEO, THE AMOUNT OF DEVICE MOVEMENT OBSERVED IN THE CLIP IS AN INDICATOR THAT THE DEVICE /STAPLE CARTRIDGE/KNIFE WERE BEING CHALLENGED. JUST WHAT MAY HAVE CHALLENGED THE DEVICE COULD NOT BE DETERMINED SINCE DEVICE PLACEMENT WAS NOT INCLUDED IN THE VIDEO CLIPS. BASED ON THE VIDEO EVIDENCE PROVIDED, IT COULD NOT BE DETERMINED THE POTENTIAL CAUSE FOR THE DEVICE NOT OPENING. HANDS ON ANALYSIS OF THE DEVICE AND STAPLE CARTRIDGE MAY PROVIDE THE EVIDENCE REQUIRED TO DETERMINE THE CAUSE OF THIS COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT HEMICOLECTOMY, IN THE FIRST ACTIVATION THE SURGEON FIRED THIS DEVICE ON THE PATIENT'S SIGMOID/RECTUM. WHEN HE REACHED THE FOURTH STROKE OF THE FIRING TRIGGER, AFTER WHICH THE KNIFE SHOULD RETURN TO HOME POSITION, HE NOTICED THAT THE KNIFE HAD NOT RETURNED TO A CORRECT POSITION, THUS MAKING IT IMPOSSIBLE TO REOPEN THE INSTRUMENT. THE SURGEON USED THE CORRECT EMERGENCY PROCEDURE TO MAKE THE KNIFE RETURN (I.E. PUSHED THE RED SWITCH DOWNWARD AND SQUEEZED THE FIRING TRIGGER COMPLETELY). HOWEVER, HE FELT THAT THE FIRING TRIGGER FAILED TO REACT; IT SEEMED AS IF IT WAS LOOSE AND DISCONNECTED FROM THE INTERNAL RACK-AND-PINION MECHANISM. SINCE THE KNIFE WAS STILL IN THE WRONG POSITION, THE SURGEON USED BIPOLAR SCISSORS TO TRY TO MAKE IT RETURN TO ITS PROPER POSITION, BUT UNFORTUNATELY TO NO AVAIL. WITH THE SAME SCISSORS THE SURGEON LEVERAGED AND SLIGHTLY OPENED THE JAWS OF THE DEVICE. THANKS TO THIS MANEUVER, THE TISSUE SLED LATERALLY AND FREED THE DEVICE. THE TISSUE WAS CORRECTLY STAPLED. THE DEVICE WAS REMOVED FROM THE PATIENT ARTICULATED AND TOGETHER WITH THE TROCAR. THE SURGEON THEN INTRODUCED A NEW TROCAR, AND SUCCESSFULLY CARRIED OUT AND FINISHED THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. PROCEDURE WAS PROLONGED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134042 ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU4W

    Patients

    Seq Age Sex Outcome Treatment
    1