BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3122109 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02447
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON REMOVED THE ECHELON 60A STAPLER BY STAPLING WITH AN ENDOPATH35 STAPLER BELOW AND ABOVE THE RENAL HILUM WHERE THE EC60A WAS LOCATED. THIS ALLOWED THE PROCEDURE TO BE COMPLETED LAPAROSCOPICALLY. HE MENTIONED THAT THERE WAS NO FURTHER DAMAGE TO THE PATIENTS TISSUE BUT THAT IT WAS EXTREMELY DIFFICULT TO STAPLER ABOUT AND BELOW THE ECHELON STAPLERS TO REMOVE IT. THE PROCEDURE WAS DELAYED, SPECIFIC TIME UNKNOWN BUT THERE WAS NO HARM TO THE PATIENT. THE PATIENT CONDITION WAS STABLE AND DISCHARGED LIKE THEY NORMALLY WOULD BE. THE ANALYSIS FOUND THAT THE DEVICE WAS RECEIVED WITH THE KNIFE JAMMED AND WITH AN ECR60W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. AFTER FURTHER ANALYSIS A CLIP WAS FOUND LODGED BEHIND THE KNIFE, PREVENTING IT FROM RETURNING AND THUS, THE DEVICE WOULD NOT OPEN. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE CLIP WAS REMOVED AND THE KNIFE WAS ABLE TO RETURN TO THE HOME POSITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE 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 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 NEPHRECTOMY PROCEDURE, THE DEVICE JAMMED MID-FIRE AND THE REVERSE STROKE DID NOT WORK. THE SURGEON WAS UNABLE TO RETURN THE KNIFE BLADE. THE DEVICE WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224076 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CT2U

    Patients

    Seq Age Sex Outcome Treatment
    1