BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1831640 · Received January 8, 2008

    Report

    Report Number
    1527736-2008-00262
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    November 14, 2007
    Report Date
    November 15, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A PARTIALLY FIRED CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND THE DEVICE FIRED WAS NOTED TO BE NON-CONFORMING, AS THE FIRING TRIGGER SOME TIMES WOULD NOT ENGAGED THE FIRING MECHANISM. ALTHOUGH THE FIRING MECHANISM WAS FOUND DAMAGED THE DEVICE CUT AND FORMED ALL THE STAPLES AS INTENDED. IN ADDITION THE RETURNED DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE PIN PAWL WAS NOTED TO BE NOT PROPERLY FLARED, CAUSING THE FIRING MECHANISM NOT TO PROPERLY OPERATE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRE SPECS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL VAGINAL HYSTERECTOMY PROCEDURE, THE STAPLER MALFUNCTIONED. ON THE SECOND FIRING ON THE RIGHT SIDE OF THE UTERUS, STAPLER ONLY FIRED ON THE FIRST FIRE OF THE FIRING HANDLE. IT DISENGAGED AND WOULD NOT ALLOW THE SECOND OR THIRD FIRING SEQUENCES. THE STAPLER WAS RELOADED AND WITH THE SAME RESULT. THE CASE WAS FINISHED WITH CLAMPS AND SUTURES WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA C4FL26

    Patients

    Seq Age Sex Outcome Treatment
    1