BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1210137 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02466
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 29, 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 ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION AND TESTING. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. IN ADDITION, 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 UNKNOWN PROCEDURE, THE DEVICE'S TISSUE PAD CAME OFF DURING USE AND WAS RETRIEVED. 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 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR