BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3803025 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03159
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 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
    NJ, US
    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 WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ONLY RELOAD BEING RETURNED FOR ANALYSIS AS STAPLER DISPOSED OF. THE ANALYSIS FOUND THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED FOR EVALUATION. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT OUTER ROW FULLY FIRED, LEFT TWO INNER ROWS PARTIALLY FIRED 1/5. DURING FURTHER EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. ADDITIONALLY, THE CARTRIDGE PAN WAS BENT AND DISLODGED AT PROXIMAL END. 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, THE SURGEON FIRED DEVICE FOR SECOND TIME USING GREEN RELOAD AND BUTTRESSING MATERIAL. THE SURGEON NOTICED A LOWER TONE WHILE FIRING AND WHEN DEVICE WAS OPENED AFTER FIRING, IT WAS NOTED THAT THE DEVICE CUT AND STAPLED THREE ROWS OF STAPLES ON THE PATIENT SIDE, BUT NO STAPLES WERE DEPLOYED ON THE SPECIMEN SIDE. THERE WAS NO BLEEDING. THE SURGEON VISUALLY INSPECTED THE STAPLE ROWS ON PATIENT SIDE AND ALL WERE DEPLOYED AS INTENDED. THE SURGEON DID A LEAK TEST AND THERE WAS NO LEAK. THE CASE WAS COMPLETED WITH SAME DEVICE AND NEW RELOADS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED BUT ONE RELOAD WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281548 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PLE60A| ECR60G