BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3971083 · Received July 31, 2014

    Report

    Report Number
    3005075853-2014-05374
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 22, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE ECR60D CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS AND CARTRIDGE BODY WAS NOTED TO BE DAMAGED. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED. 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. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. 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 LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WITH POWERED DEVICE, THE SURGEON USED A GOLD RELOAD FOR THE SECOND FIRE TO CUT THE STOMACH. THE SURGEON EXAMINED THE STAPLE LINE AND NOTICED THAT THERE WERE OPEN STAPLES THAT DIDN¿T CLOSE TO A PERFECT "B" SHAPED AS EXPECTED. THE SURGEON CONTINUED CUTTING AND STAPLING THE STOMACH USING GREEN AND BLUE RELOADS AND THEN WENT BACK TO THE SUSPECTED AREA AND SUTURED THE SEGMENT (60 MM). AFTER SUTURING THE SUSPECTED AREA, HE USED METHYLENE BLUE TO BE SURE THERE ARE NO LEAKS ¿ THE TEST ENDED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447888 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E74D

    Patients

    Seq Age Sex Outcome Treatment
    1