BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3172583 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03053
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES A AND B WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED ¿ EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. DEVICE A 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. DEVICE B WAS FUNCTIONALLY TESTED ON THE GENERATOR AND THE HAND CONTROL SWITCH ASSEMBLY WAS NOT FUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH. DURING FUNCTIONAL TESTING ON GEN11 AN INSTRUMENT ERROR WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR 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. DEVICE B: BATCH J9152T, MFG DATE: 5-14-2012, EXP DATE: 5-14-2017.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PRIOR TO AN UNKNOWN PROCEDURE THE BLADE OF THE DEVICE BROKE AS SOON AS ACTIVATED FOR BOTH THE PIECES OF THE DEVICE. TWO DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274107 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE