BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1822897 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05021
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    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) CLOSURE TRIGGER TOP THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITHOUT CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE RELOAD WAS LOADED IN THE DEVICE WITHOUT ANY DIFFICULTIES NOTED. 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 PULLING THE CLOSURE TRIGGER OPEN IN AN ATTEMPT TO OPEN THE DEVICE. 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. THIS IN TURN CAN THEN RESULT IN THE RED SWITCH BEING LOCKED OUT IF THE FIRING TRIGGER IS NOT IN ITS FULL OPEN POSITION. THE DEVICE OPENED AND CLOSED AS INTENDED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (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 A ROUX-EN-Y PROCEDURE, THE DEVICE JAWS WOULD NOT COMPLETELY CLOSE. THEY SUSPECTED THE CARTRIDGE WAS NOT LOADED CORRECTLY THEREFORE THE CARTRIDGES WERE REMOVED AND A NEW ONE WAS INSERTED. THE DEVICE JAWS STILL WOULD NOT CLOSE COMPLETELY. SEVERAL CARTRIDGES WERE INSERTED AND THE SAME EVENT OCCURRED. FINALLY A NEW DEVICE WAS USED AND IT CLOSED AND FIRED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT. THE INITIAL DEVICE WILL BE RETURNED FOR ANALYSIS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RE7A

    Patients

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