BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3040920 · Received April 8, 2013

    Report

    Report Number
    3005075853-2013-01636
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION WITH THE BLADE INTACT AND NOT BROKEN OFF AS REPORTED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND DURING FUNCTIONAL TESTING ON A GENERATOR AN INSTRUMENT ERROR WAS DISPLAYED. THE BLADE WAS CRACKED DUE TO CONTACT WITH METAL. THE LOCATION OF THE BREAK IS INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. A PROBABLE CAUSE OF AN REPLACE INSTRUMENT ERROR CODE IS BLADE DAMAGE. THE DEVICE WILL STOP ACTIVATING, AND DISPLAY INSTRUMENT ERROR SCREEN WHEN THE BLADE BECOMES DAMAGED. THE ¿REPLACE INSTRUMENT¿ YELLOW MESSAGE SCREEN DISPLAYED AFTER RECEIVING TWO CONSECUTIVE YELLOW ALERT SCREEN MESSAGES AND IS ADVISING OF POTENTIAL BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE.

    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 THAT THE DEVICE WAS USED DURING A ROBOTIC COLECTOMY AND ROBOTIC PROSTATECTOMY. THE GENERATOR CONTINUED TO DISPLAY "REPLACE INSTRUMENT." AFTER TROUBLESHOOTING AND THE RESULTS WERE THE SAME. THE DEVICE WAS FOUND AFTER THE TROUBLESHOOTING THAT THE BLADE WAS BROKEN. THE PATIENT HAD PROSTATE CANCER AND HAD BEEN THROUGH RADIATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ONE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142896 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J9335J

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE