BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3823912 · Received May 21, 2014

    Report

    Report Number
    3005075853-2014-03390
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE EC60 DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITH AN ECR60B CARTRIDGE LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE; HOWEVER, THE CARTRIDGE WAS LOADED AND REMOVED FROM THE DEVICE AS INTENDED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND THE CLOSURE LINK PIN WAS FOUND LOOSE AND OUT OF ITS INTENDED POSITION. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLOSURE LINK PIN TO LOOSE ITS INTENDED POSITION, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE DEVICE DELIVER ANY STAPLES OR A CUT LINE BEFORE IT JAMMED? YES. WERE THE JAWS OF THE DEVICE EVENTUALLY OPENED?NA. WHAT IS THE PRODUCT CODE FOR THE STAPLER? EC60. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NA. FURTHER EXPLANATION FROM REP: I'VE BEEN INFORMED THAT AFTER DR (B)(6) HAS CLOSED THE JAW ON TISSUE WITH THE CLOSING TRIGGER, HE PULLED THE FIRING TRIGGER BUT THE KNIFE DID NOT MOVE FORWARD. SO HE THOUGHT THAT PERHAPS THERE WAS SOMETHING WRONG WITH THE CARTRIDGE SO HE OPENED THE JAW TO REMOVE THE INSTRUMENT FROM TISSUE AND TOOK THE INSTRUMENT OUT OF THE BODY. THEN, OUT OF THE BODY, HE CLOSED THE JAW BUT COULD NOT REOPEN IT. IT WAS COMPLETELY STUCK. HE HAD TO OPEN A NEW INSTRUMENT. THEREFORE, I CONFIRM THERE WAS NO TISSUE DAMAGE CAUSE TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE USE OF FOUR CARTRIDGES THE DEVICE JAMMED AND COULD NOT BE OPENED AND THE RELOAD COULD NOT BE REMOVED. THE SURGEON STATES, HE CLOSED THE JAW ON TISSUE WITH THE CLOSING TRIGGER, HE PULLED THE FIRING TRIGGER BUT THE KNIFE DID NOT MOVE FORWARD. SO HE THOUGHT THAT PERHAPS THERE WAS SOMETHING WRONG WITH THE CARTHRIDGE SO HE OPENED THE JAW TO REMOVE THE INSTRUMENT FROM TISSUE AND TOOK THE INSTRUMENT OUT OF THE BODY. THEN, OUT OF THE BODY, HE CLOSED THE JAW BUT COULD NOT REOPEN IT. IT WAS COMPLETELY STUCK. HE HAD TO OPEN A NEW INSTRUMENT. THEREFORE I CONFIRM THERE WAS NO TISSUE DAMAGE CAUSE TO PATIENT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303183 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E62V

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60B