BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3846426 · Received June 3, 2014

    Report

    Report Number
    3005075853-2014-03757
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 27, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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 TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE TIP OF THE INSTRUMENT BROKE OFF THE INSTRUMENT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE TIP WAS RETRIEVED AND THE CASE WAS COMPLETED WITH NO CONSEQUENCE TO THE PATIENT. ONE DEVICE WILL BE RETURNED FOR ANALYSIS BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323547 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA K92X5V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE