BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1190815 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02177
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP BROKE OFF. THE DEVICE WILL ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 OR A SOLID TONE ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A POSSIBLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SUPER CERVICAL HYSTERECTOMY PROCEDURE, THE DEVICE STARTED SHUTTING DOWN WITH AN ERROR CODE 5 AND THEN BEEPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMONIC ACE 36CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC. NA E4L48V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE