BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3233866 · Received July 18, 2013

    Report

    Report Number
    3005075853-2013-03608
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED ¿ EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON THE GEN11 GENERATOR, THE ¿INSTRUMENT ERROR¿ ALERT WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR SCREEN IS BLADE DAMAGE. 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¿ FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC MAZE PROCEDURE THE DEVICES ACTIVE BLADE BROKE OFF AND WAS IN THE PATIENT. ALL PIECES WERE RETRIEVED THROUGH THE TROCAR AND THE SITE WAS VISUALLY EXAMINED. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS RETURNING WITHOUT THE BLADE. THERE IS A NOTE FROM THE O.R. WITH THE DEVICE THAT STATES ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335722 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92P05

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE