BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1904316 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00578
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 7, 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
    BR
    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 AN ERROR CODE 5. 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 W/O 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 W/O 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATIC LOBECTOMY PROCEDURE THE GENERATOR STOPPED WORKING INDICATING A PROBLEM WITH THE SHEARS. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HD28

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR