BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 1896817 · Received November 11, 2010

    Report

    Report Number
    3005075853-2010-06424
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 21, 2010
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ARTICULATION LINK; CLOSURE TRIGGER TOP THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT FIRED, AND FORMED ALL THE STAPLES AS INTENDED. HOWEVER, THE FIRING TRIGGER WAS NOT WORKING PROPERLY ON EACH STROKE AS THE PAWL WAS NOT ENGAGING WITH THE DRIVE BAR AT REPEATED ATTEMPTS. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND WEAR WAS FOUND ON THE RIGHT SIDE OF THE CLOSURE TRIGGER DUE TO THE CLAMP FIRST LOCKOUT PIN ON THE GEARED TRIGGER PLATE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT IF THE APPLIED LOAD IS HIGH ENOUGH. ONCE THE CLOSURE TRIGGER TOP COMPONENT IS DAMAGED, THEN ANY ADDITIONAL ACTUATION OF THE FIRING TRIGGER CAN CAUSE IT TO RUB AGAINST THE NOW BROKEN OR BENT CLOSURE TRIGGER ASSEMBLY. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). 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 AN OPEN SPLENECTOMY PROCEDURE, ON THE FIRST FIRING THE DEVICE WAS PLACED ON THE VESSEL AND FIRED. THERE WAS SEVERE BLEEDING. THE AREA WAS OVER SEWED TO CONTROL THE BLEEDING. A SECOND FIRING OF THE DEVICE WORKED FINE. THERE WAS NO PATIENT IMPACT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T35V

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)