BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3150236 · Received June 6, 2013

    Report

    Report Number
    3005075853-2013-02843
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE TISSUE PAD IN GOOD PHYSICAL CONDITION AND PROPERLY ATTACHED TO THE CLAMP ARM. THE BLADE WAS SCRATCHED AND CRACKED. THE DEVICE WAS RETURNED WITH WHAT APPEARED TO BE A BLADE FROM ANOTHER INSTRUMENT. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 INSTRUMENT ERROR SCREEN WAS DISPLAYED. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN YELLOW ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿ OR ¿BLADE ERROR DETECTED¿ OR "RELAX PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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 DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT HAD THE TISSUE PAD DETACHED, NOT MELTED AWAY, BUT A PIECE BROKE OFF. NOTHING FELT INTO THE PATIENT AND THE PIECE HAS BEEN RETRIEVED. CUSTOMER CANNOT PROVIDE ANYMORE DETAILS ABOUT THE CIRCUMSTANCES IN WHICH THE ISSUE OCCURRED. NO PATIENT CONSEQUENCE WAS REPORTED. ONE DEVICE IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250412 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE