BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1822370 · Received August 17, 2007

    Report

    Report Number
    1527736-2007-05530
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Date of Event
    September 12, 2006
    Report Date
    September 14, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BURNT AND CRACKED. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT WHEN ATTEMPTING TO ACTIVATE THE DEVICE ON A GEN04 GAVE AN ERROR CODE 5. VISUAL EXAMINATION FOUND AN AREA OF BLADE THAT WAS DISCOLORED DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. FURTHER ANALYSIS FOUND A CRACK PROPAGATING FROM THE HEAT-AFFECTED AREA OF THE BLADE. THIS FAILURE IS CAUSED DUE TO ACTIVATION OF THE DEVICE WHILE CLAMPED WITHOUT TISSUE BEING PRESENT. FOR THIS REASON, THE FOLLOWING STATEMENTS WERE INCLUDED IN THE INSTRUCTIONS FOR USE: "CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT." WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AN NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAVH PROCEDURE, THE NURSE WAS DOING NORMAL CALIBRATION OF INSTRUMENT, IN GENERATOR TEST IN PROGRESS NORMALLY, BUT AFTER THAT ONLY ERROR SOUND. NO ERROR CODE ON DISPLAY. THEY TRY TO CALIBRATE INSTRUMENT AGAIN BUT SAME PROBLEM. ALSO THE INSTRUMENT WAS MAKING VERY HIGH SOUND. HAND PIECE AND GENERATOR TESTED ACCORDING TO ADVANCED TROUBLE SHOOTING MANUAL. BOTH OK. NOT NOTED HOW CASE WAS COMPLETED. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA C4ER7U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE