BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3940501 · Received July 17, 2014

    Report

    Report Number
    3005075853-2014-05019
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60T LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/4. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND 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 DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE SURGEON USES TWO DEVICES ON EACH SLEEVE WITH GORE SEAMGUARD. FIRST FIRING WAS FINE WITH GUN NUMBER ONE USING A BLACK RELOAD WITH SEAMGUARD. SECOND FIRING = FIRST FIRING OF GUN NUMBER TWO USING BLACK RELOAD AND SEAMGUARD. DEVICE GAVE AUDIBLE FEEDBACK OF VERY THICK TISSUE. SURGEON USED PULSE TECHNIQUE AND STOPPED HALFWAY THROUGH FIRING. PAUSED AND SAID HE MAY CHOOSE TO REVERSE THE FIRING MIDWAY DUE TO THE SOUND. HE DECIDED TO FORGE AHEAD. STAPLE FORMED ON THE SPECIMEN SIDE AND NOT ON THE PATIENT SIDE. THE OTHER STAPLER WAS USED ALONG WITH ANOTHER GUN. THE SURGEON FIRED ADJACENT TO THE UNFORMED LINE OR MEDIALLY WITH A BLACK RELOAD WITH NO SEAMGUARD. DEVICE INDICATED AUDIBLY THAT THE TISSUE WAS THICK. STAPLES FORMED PROPERLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418832 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60T