BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE ATT

    MDR report key: 5590564 · Received April 20, 2016

    Report

    Report Number
    3005075853-2016-02164
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 30, 2016
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SECONDARY ANALYSIS PERFORMED ON THE BLADE. THE BLADE CONTAINED SUPERFICIAL SCRATCHES CONSISTENT WITH METAL. SCRATCHES WERE NOT ON THE CUTTING\PAD CONTACT SURFACE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS VISUALLY CONFORMING WITH SIGNS OF NORMAL USAGE. THE DEVICE FUNCTIONED AS EXPECTED WHEN TESTED WITH AN HP054 AND A GEN11. THE MAX AND MIN BUTTONS WERE USED IN PERFORMING THE CUT TEST ON MEDIA. THE INSTRUMENT WAS IN THE EXPECTED POWER RANGE AS OBSERVED THROUGH BIOMED MODE. THE DEVICE WAS DISASSEMBLED AND NO ISSUES WERE FOUND. THE AMOUNT OF ENERGY DELIVERED TO THE TISSUE AND RESULTANT TISSUE EFFECTS ARE A FUNCTION OF MANY FACTORS, INCLUDING THE POWER LEVEL SELECTED; BLADE CHARACTERISTICS, GRIP FORCE, TISSUE TENSION, TISSUE TYPE, PATHOLOGY AND SURGICAL TECHNIQUE. MAX POWER IS SET AT POWER LEVEL 5 AND CANNOT BE ADJUSTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT OF RELAX PRESSURE ON BLADE, HEMOSTASIS ISSUES, AND SOLID TONE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW LONG WAS THE FIRST DEVICE USED BEFORE IT WAS REPLACED? NO INFORMATION WHAT WAS THE EXPERIENCE LEVEL OF THE USER? NO INFORMATION. WERE THERE ANY GENERATOR ERRORS OR ALERT SCREENS WITH THE DEVICE? RELAX PRESSURE ON BLADE ON ALERT SCREEN. WHY WAS THE DEVICE REPLACED?---BECAUSE A SOLID TONE WAS HEARD SEVERAL TIMES FROM THE BEGINNING OF USE. HOW WAS THE DETERMINATION OF THE 1000 CC NOTED? FROM DRAIN. WHERE THERE OTHER TECHNOLOGIES AVAILABLE TO COMPLETE THE PROCEDURE? ADDITIONAL SUTURE WAS PERFORMED TO STOP THE BLEEDING IN THE REOPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A VATS LOBECTOMY, A SOLID TONE WAS HEARD SEVERAL TIMES FROM THE BEGINNING OF USE. ALTHOUGH THE DEVICE WAS REPLACED, THE EVENT CONTINUED WITH THE SECOND ONE. THERE WAS NO EXTRA HP054 WHEN THIS EVENT OCCURRED, SO THE HP054 WAS NOT REPLACED. THEREFORE, THE HAR23 CONTINUED TO BE USED AT A PHYSICIAN'S DISCRETION TO COMPLETE THE CASE. THE SOLID TONE WAS HEARD UNTIL THE OPERATION WAS COMPLETED. DURING THE INITIAL PROCEDURE, THE TOTAL AMOUNT OF BLEEDING WAS ABOUT 50CC. WHEN THE PATIENT RECOVERED FROM ANESTHESIA AFTER THE OPERATION, BLOOD PRESSURE ROSE UP TO 200 AND 1000CC OF BLEEDING OCCURRED. REOPERATION WAS PERFORMED. SUTURING WAS PERFORMED TO STOP BLEEDING. BLOOD TRANSFUSION WAS REQUIRED, BUT THE AMOUNT WAS UNKNOWN. IT WAS CONFIRMED THAT THE BLEEDING OCCURRED FROM THE BRONCHIAL ARTERIES THAT THE DEVICE HAD BEEN USED ON. THE PATIENT IS STABLE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244031 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA M93F4Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention