BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN RELOAD FOR ECHELON 60

    MDR report key: 3884095 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04128
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: DAMAGED CARTRIDGE, DAMAGED ONE PIECE SLED, DAMAGED DRIVERS. THE ANALYSIS FOUND THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS. IN ADDITION, THE CARTRIDGE PAN WAS NOTED TO BE DISLODGED AT PROXIMAL END. THE RELOAD WAS RECEIVED WITH THE LEFT SIDE FULLY FIRED, RIGHT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/2. 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, THE RELOAD JAMMED AND DID NOT FULLY STAPLE. IT WAS REPORTED THE CUT LINE WAS COMPLETE AND THE STAPLE LINE WAS INCOMPLETE. SOME STAPLES THAT WERE DELIVERED WERE REPORTED TO BE MALFORMED. THIS OCCURRED ON THE 2ND FIRING WITH A PSE60A DEVICE. THE DEVICE WAS RELOADED WITH ANOTHER GREEN CARTRIDGE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. A GREEN RELOAD WAS USED WITH THE FIRST FIRING AND THE BMI OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360562 GREEN RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DR5W

    Patients

    Seq Age Sex Outcome Treatment
    1 PSE60A