BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3813616 · Received May 15, 2014

    Report

    Report Number
    3005075853-2014-03277
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 5, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED AND NOT BROKEN OFF AS IT WAS REPORTED. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. THE TIP OF THE BLADE BROKE OFF DURING ANALYSIS. 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 ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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 A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE ACTIVE BLADE BROKE OFF. IT WAS NOT REPORTED HOW IT WAS RETRIEVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT REPORTED. THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290287 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE