BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4172828 · Received October 15, 2014

    Report

    Report Number
    3005075853-2014-07078
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 24, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT ONE EC60A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND LOADED WITH A 45 MM RELOAD. THE RELOAD WAS NOTED TO BE UNFIRED. PLEASE NOTE THAT A 60MM DEVICE IS DESIGNED TO WORK ONLY WITH 60MM CARTRIDGES, FOR FURTHER LOADING INSTRUCTIONS PLEASE REFER TO THE ECHELON FLEX 60MM IFU. IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO FIRE A 60MM DEVICE WITH A 45MM CARTRIDGE RELOAD, THE DEVICE WILL LOCK OUT; IN ORDER TO OPEN A LOCKED DEVICE A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. IN ADDITION, THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. THE KNIFE WAS RETURNED TO THE HOME POSITION AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A 60 MM RELOAD AND IT ACHIEVED A COMPLETE FIRE SEQUENCE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED AS INTENDED.

    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: RESPONSE FROM THE AFFILIATE: WE RECEIVED ADDITIONAL INFORMATION REGARDING THIS COMPLAINT: FEMALE, (B)(6) YEARS OLD, OBESE PATIENT. PROCEDURE: RECTOSIGMOID AND INNER GENITALIA RESECTION, SUBTOTAL COLECTOMY AND FINAL ADENOSTOMA, APPENDECTOMY. DIAGNOSIS: OVARIAN CANCER FIGO 3 C. NO NEOADJUVANT THERAPY. DURING FIST FIRING THE DEVICE COULD NOT BE FIRED AND COULD ALSO NOT BE OPENED. HAD TO BE CUT OUT OF TISSUE WITH APPROX. 2 CM OF TISSUE. CARTRIDGE COLOR: GOLD, ECR60D, LOT L4EH7Z. PATIENT SHOWS A NORMAL POST-SURGERY HEALING PROCESS, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER CLOSING INSTRUMENT, IT DID NOT FIRE AT ALL AND COULD NOT BE OPENED. IT HAD TO BE CUT OUT FROM TISSUE. NO FURTHER INFORMATION IS AVAILABLE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653120 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR RELOAD - ECR60D