BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 1822382 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05441
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    July 13, 2007
    Report Date
    July 16, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST COULD BE PERFORMED WITH THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND YOKE TEETH WERE FOUND BROKEN. THE RETURNED CARTRIDGE WAS LOADED INTO A TEST DEVICE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE TEETH BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED ON TISSUE THICKER THAN INDICATED. IN ADDITION, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG 45 ENDOCUTTER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4H256

    Patients

    Seq Age Sex Outcome Treatment
    1