BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2233234 · Received September 2, 2011

    Report

    Report Number
    1527736-2011-00028
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOSURE TRIGGER TOP. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED DISASSEMBLED AND BROKEN AND WITHOUT CARTRIDGE RELOAD PRESENT. THE INTERNAL COMPONENTS WERE ANALYZED 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. EVENT COULD NOT BE CONFIRMED AS NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. 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). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LUNG RESECTION. THE DEVICE WAS STAPLING ON THE VESSEL AND HE THOUGHT THE STAPLES WERE FIRING, BUT THE BLADE WOULD NOT RETURN. THE JAWS WOULD NOT OPEN. AFTER SEVERAL TIMES, THE DEVICE WAS OPENED MANUALLY. UNKNOWN HOW CASE WAS COMPLETED. UNKNOWN IF THERE WAS ANY ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1