BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1823639 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07769
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Report Date
    October 3, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DUE TO THE DAMAGE TO THE BLADE, IT WAS CONFIRMED THAT THE DEVICE WAS NON-FUNCTIONAL. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS NOTED. BECAUSE OF THE RETURNED CONDITION OF THE BLADE (BROKEN) WE WERE UNABLE TO VERIFY IF THE BLADE HAD TEMPERATURE ISSUES. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. FOR THIS REASON THE FOLLOWING STATEMENTS WERE INCLUDED IN THE INSTRUCTIONS FOR USE: "AVOID ACCIDENTAL CONTACT WITH ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. 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. THE INSTRUCTIONS FOR USE STATE: TO AVOID USER OR PATIENT INJURY IN THE EVENT THAT ACCIDENTAL ACTIVATION OCCURS, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT SHOULD NOT BE IN CONTACT WITH THE PATIENT, DRAPES, OR FLAMMABLE MATERIALS WHILE NOT IN USE. DURING PROLONGED ACTIVATION IN TISSUE, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL 7 CM OF THE SHAFT MAY BECOME HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, OR OTHER UNINTENDED SITES AT ALL TIMES. INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES, SUCH AS BONE, MAY RESULT IN BLADE HEATING AND SUBSEQUENT BLADE FAILURE, AND SHOULD BE AVOIDED. AUDIBLE HIGH-PITCHED TONES, RESONATING FROM THE BLADE OR HAND PIECE, ARE AN ABNORMAL CONDITION AND AN INDICATOR THAT THE BLADE OR HAND PIECE IS NOT OPERATING PROPERLY. THE TONES MAY BE AN INDICATOR THAT THE HAND PIECE IS BEYOND ITS USEFUL LIFE OR THAT THE BLADE HAS NOT BEEN ATTACHED PROPERLY, WHICH MAY RESULT IN ABNORMALLY HIGH SHAFT TEMPERATURES AND USER OR PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO COLECTOMY, THE SHAFT OF THE DEVICE GOT HOT AND IT STOPPED WORKING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HM51

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR