BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3950440 · Received July 22, 2014

    Report

    Report Number
    3005075853-2014-05148
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 9, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE STAPLES FORMED COMPLETELY ON THE RIGHT SIDE OF CUT LINE. ON THE LEFT SIDE OF THE CUT LINE THE VERY OUTER ROW OF STAPLES FORMED COMPLETELY. ABOUT ¼ OF THE STAPLES ON THE 2 MOST INNER ROWS FORMED COMPLETELY. THE STAPLES ON DISTAL ¾ OF THE 2 MOST INNER ROWS DID NOT FORM AT ALL; THE STAPLES REMAINED IN THE CARTRIDGE. THE ANALYSIS FOUND THAT ONE ECR60G 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 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. 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 ON THE THIRD FIRING WITH A GREEN RELOAD WITH PERISTRIPS THE STAPLES ONLY FORMED ON ONE SIDE OF THE CUT LINE. ON THE OTHER SIDE OF THE CUTLINE THE STAPLES DID NOT FORM AND SOME STAPLES REMAINED IN THE CARTRIDGE. THE SURGEON REPORTED THAT THE MOTOR SOUNDED DIFFERENT ON THIS FIRING. THE AREA WAS STAPLED WITH ANOTHER GREEN RELOAD AND THE SAME DEVICE FOR 4-5 FIRINGS. THE CASE WAS COMPLETED WITH THIS SAME DEVICE AND ADDITIONAL GREEN RELOADS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428265 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EE61

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PLE60A