BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1150951 · Received September 5, 2008

    Report

    Report Number
    1527736-2008-03951
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/28/2008. EVALUATION SUMMARY: THE DEVICE A WAS RECEIVED IN GOOD CONDITION. NO VISIBLE DAMAGE WAS NOTED. THE HAND-ACTIVATION CONTACTS WERE IN GOOD CONDITION. THE DEVICE WAS TESTED ON A GENERATOR AND DISPLAYED AN ERROR CODE 7, IT WAS FOUND THAT THE HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL. "IT COULD NOT BE COMPLETED THE INITIAL TEST". THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP BROKE OFF. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OF 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 AN UNK PROCEDURE, THE INSTRUMENT WAS NOT WORKING. THEY HAVE REPLACED THE INSTRUMENT. THE SECOND INSTRUMENT WAS NOT PASSING THE PRE RUN TEST. THEY TOOK A THIRD INSTRUMENT AND IT WAS OK. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA E4DK4L

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE