BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECHELON LINEAR CUTTER

    MDR report key: 3895178 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04403
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DAMAGED CARTRIDGE, DAMAGED ONE PIECE SLED, DAMAGED DRIVERS. BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT PLE60A DEVICE, UTILIZING A GREEN CARTRIDGE, UNFORMED AND NON-DEPLOYED STAPLES CAN BE CONFIRMED, HOWEVER, THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE. HANDS ON ANALYSIS OF THE DEVICE AND CARTRIDGE MAY PROVIDE THE ADDITIONAL EVIDENCE NEEDED TO DETERMINE THE CAUSE OF THE COMPLICATION. HANDS-ON ANALYSIS: AN ECR60G CARTRIDGE RELOAD WAS RECEIVED INSTEAD OF THE REPORTED PLE60A. THE ANALYSIS FOUND THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/16. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VERTICAL SLEEVE GASTRECTOMY PROCEDURE, ON THE THIRD FIRING OF THE DEVICE WHILE USING A GREEN RELOAD, THE DEVICE WAS FIRED AND THEN REMOVED. THE DEVICE CUT BUT DID NOT STAPLE ON THE PATIENT SIDE OF THE CUT LINE. BLEEDING OCCURRED AND SURGEON IRRIGATED AND OVERSEWED THE STAPLE LINE. THE AMOUNT OF BLEEDING COULD NOT BE QUANTIFIED BUT REP, WHO WAS PRESENT FOR PROCEDURE, REPORTED THAT NO BLOOD PRODUCTS WERE GIVEN THAT HE WAS AWARE OF. THE CASE WAS COMPLETED WITH SAME DEVICE AND NEW RELOADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372168 PWRD ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G