BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE ATT

    MDR report key: 4824904 · Received June 8, 2015

    Report

    Report Number
    3005075853-2015-03398
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UNDER MAGNIFICATION, SCRATCHES WERE SEEN ON THE BLADE. THE NATURE OF THE SCRATCHES SUGGESTS CONTACT WITH METAL, AND CONTACT THAT WAS MORE THAN INCIDENTAL. THIS METAL CONTACT MAY HAVE BEEN THE CAUSE OF THE SPARK THAT WAS NOTED IN THE EVENT DESCRIPTION. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GEN1 GENERATOR FOR FUNCTIONAL TESTING. THE DEVICE PASSED PRE-RUN TESTING AND ACTIVATED USING THE MIN AND THE MAX BUTTONS. AT TIMES DURING USE OF THE MAX BUTTON, THE GEN11 DISPLAYED AN ERROR THAT TWO BUTTONS WERE BEING SIMULTANEOUSLY PRESSED. THE DEVICE CUT THROUGH CHAMOIS WITHOUT ANY DIFFICULTY. THE DEVICE WAS DISASSEMBLED. ALL COMPONENTS APPEARED TO BE CONFORMING. NO MANUFACTURING ANOMALIES WERE NOTED. THE FEP SHEATH WAS PRESENT AND CORRECT (BLACK). NO SPARKS WERE OBSERVED AT ANY TIME DURING DEVICE ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UNDER MAGNIFICATION, SCRATCHES WERE SEEN ON THE BLADE (PICTURES ATTACHED). THE NATURE OF THE SCRATCHES SUGGESTS CONTACT WITH METAL, AND CONTACT THAT WAS MORE THAN INCIDENTAL. THIS METAL CONTACT MAY HAVE BEEN THE CAUSE OF THE SPARK THAT WAS NOTED IN THE EVENT DESCRIPTION. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GEN1 GENERATOR FOR FUNCTIONAL TESTING. THE DEVICE PASSED PRE-RUN TESTING AND ACTIVATED USING THE MIN AND THE MAX BUTTONS. AT TIMES DURING USE OF THE MAX BUTTON, THE GEN11 DISPLAYED AN ERROR THAT TWO BUTTONS WERE BEING SIMULTANEOUSLY PRESSED (THE TWO ACTIVATIONS ALERT SCREEN) WHICH IS MOST LIKELY CONTAMINATE OR CORROSION UNDER THE DOME DUE TO MOISTURE THROUGH CLEANING OR DECONTAMINATION PROCESS. THE TWO SWITCH ACTIVATION ALERT SCREEN IS NOT RELATED TO THE EVENT REPORTED NOT TO THE SPARK OBSERVED. DURING FUNCTIONAL TESTING THE DEVICE CUT THROUGH CHAMOIS WITHOUT ANY DIFFICULTY. NO SPARKS WERE OBSERVED AT ANY TIME DURING DEVICE ANALYSIS. THE DEVICE WAS DISASSEMBLED. ALL COMPONENTS APPEARED TO BE CONFORMING. NO MANUFACTURING ANOMALIES WERE NOTED. THE FEP SHEATH WAS PRESENT AND CORRECT (BLACK). THE INSTRUCTIONS FOR USE WARN: AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. 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). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND OBTAINED: WAS THE DEVICE ACTIVE AT THE TIME THE SPARK WAS OBSERVED? I THINK JUST SOON AFTER I USED IT (ACE23E) AT THE LOWER POLE THEN I SEE THE SPARK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE DOCTOR TRIED HAR23 FOR TONSILLECTOMY. THIS WAS HIS FIRST TIME USING HAR23, BUT HE HAS MULTIPLE EXPERIENCES WITH ACE23E ON TONSILLECTOMY PRIOR TO USING HAR23. AFTER REMOVING THE FIRST SPECIMEN OF TONSIL (USING HAR23), HE PROCEEDED WITH SECOND SPECIMEN, AND BEFORE HE MANAGED TO COMPLETE THE 2ND REMOVAL, HE SAW A SPARK AND THAT TRIGGERED HIM TO STOP USING HAR23, HE CONTINUED TO REMOVE THE TONSIL WITH MECHANICAL DEVICE. HE THEN USED DIATHERMY TO CONTROL SOME MINOR BLEEDERS. AS HE MOVED ON HE FELT UNCOMFORTABLE AND INSTRUCTED THE ANAESTHETIST TO CHANGE INTUBATION METHOD FROM NASAL TO ORAL, IN ORDER FOR HIM TO CONTINUE HIS RECONSTRUCTIVE WORK. WHEN THEY REMOVED THE FLEXO METALLIC TUBE, AT THE END OF THE TUBE WAS BLACK AND CHARRED. THEY DID A BRONCHOSCOPY FOR THE PATIENT. THE BRONCHOSCOPE SHOWS BURNT MARKS ALONG THE BRONCHUS. AT THE END, THE PATIENT WAS SENT TO ICU, STABLE WITH MINIMAL VENTILATOR SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368221 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L9333V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR