BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3923634 · Received July 9, 2014

    Report

    Report Number
    3005075853-2014-04780
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE EC60 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60W FULLY FIRED CARTRIDGE LOADED ON THE DEVICE. 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 WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE FIRST DEVICE DIDN'T STAPLE AT ALL, WOULDN'T FIRE. OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THIS DEVICE FIRED BUT WOULD NOT OPEN. THE SPECIMEN IS STILL IN JAWS OF THE DEVICE BECAUSE THE TECHS COULD NOT RELEASE. THERE WERE NO PATIENT CONSEQUENCES. THEY WERE ABLE TO COMPLETE THIS CASE WITH THIS DEVICE AS FIRING SEQUENCE WAS COMPLETED ACCOUNT JUST COULDN'T OPEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400490 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DR16

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60W