BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3756705 · Received April 17, 2014

    Report

    Report Number
    3005075853-2014-02655
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED, MELTED, AND A HALF PORTION WAS NOT RETURNED. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. DURING FUNCTIONAL TESTING, THE DEVICE WAS ACTIVATED FOR ABOUT ONE MINUTE WITH NO ABNORMAL HEAT OBSERVED. THE HARMONIC DEVICE IS NOT OVERHEATING AND IS FUNCTIONING AS INTENDED. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. AVOID ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO PREVENT DAMAGE TO THE TISSUE PAD. THE HARMONIC DEVICE PRODUCES HEAT IN ORDER TO CUT AND COAGULATE TISSUE. ACTIVATING THE BLADE AGAINST THE PAD WITHOUT TISSUE PRESENT IS THE MAIN FACTOR IN INCREASED OR ELEVATED DEVICE TEMPERATURE. BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT MAY RESULT IN ABNORMALLY HIGH TEMPERATURES AT THE DISTAL END OF THE SHAFT. TO PREVENT BURN INJURY, REMOVE ANY VISIBLE TISSUE BUILDUP AT THE DISTAL END OF THE SHAFT ADDITIONAL "WARNINGS" ARE IN THE IFU TO GUIDE USERS ON MINIMIZING DEVICE TEMPERATURES AND AVOIDING PATIENT OR USER INJURIES.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A PROCEDURE, 2 HAR36 DEVICES MALFUNCTIONED. THE FIRST DEVICE KEPT GIVING A "TIGHTEN ASSEMBLY" ERROR SCREEN AFTER THE DEVICE WAS TIGHTENED WITH THE TORQUE WRENCH. THE SECOND DEVICE GOT EXTREMELY HOT, MELTED THROUGH THE SURGEON'S GLOVES, AND HAD A PIECE OF THE DEVICE MELT AND FALL OFF INTO THE PATIENT'S ABDOMEN. THE PIECE THAT MELTED AND FELL OFF WAS RETRIEVED WITHOUT HAVING TO ADJUST THE SURGERY AT ALL. THE FIRST HAR36 DEVICE WAS THEN REATTACHED TO THE HAND PIECE AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235263 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L9005X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE