BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1250603 · Received November 14, 2008

    Report

    Report Number
    3005075853-2008-03041
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 21, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS TESTED FOR HAND-ACTIVATION AND THE HAND CONTROL SWITCH ASSEMBLY BUTTONS WERE NON-FUNCTIONAL. HOWEVER, WHEN THE DEVICE WAS TESTED USING THE FOOTSWITCH, THE DEVICE ACTIVATED 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. 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 PRIOR TO AN UNKNOWN PROCEDURE, THE HAND SWITCH WAS NON-FUNCTIONAL WHEN THE DEVICE WAS CHECKED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA D4JT44

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE