BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1822621 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07950
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 18, 2007
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT WHEN ATTEMPTING TO ACTIVATE THE DEVICE ON A GENERATOR GAVE A SOLID TONE. VISUAL EXAMINATION FOUND AN AREA OF THE 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. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "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." COMPLAINT INFO 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 COLECTOMY, THE DEVICE STOPPED WORKING AFTER 3 HOURS. THE HAND ACTIVATION BUTTONS WHEN PRESSED CREATED A SOLID TONE SOUND WHEN PRESSED AND THE DEVICE FAILED TO WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HL1N

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE