BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE + 7

    MDR report key: 3980761 · Received August 5, 2014

    Report

    Report Number
    3005075853-2014-05471
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION FRO SALES REP: SURGEON USED ADVANCED HEMO BUTTON FOR MAJORITY OF CASES. SURGEON USED EXTENSIVELY DURING THE PROCEDURE. ACTIVATE BUTTON ATTEMPTING TO TAKE TISSUE BUNDLES OR DIRECTLY ON A VESSEL. SURGEON NOT WAITING FOR ENTIRE TONE WHEN TISSUE HAS ALREADY FALLEN OUT OF JAWS. SURGEON TECHNIQUE DOES SWITCH FROM ADVANCED HEMO TO MIN/MAX. HOSPITAL DOES USE REMANUFACTURED HANDPIECES. AS TO GENERATOR, NO ALERT SCREENS DISPLAYED DURING THE PROCEDURE BUT A REACTIVATE SCREEN WAS DISPLAYED WHEN THE ACE+7 WAS SITTING ON THE MAYO STAND. COULD BE DUE TO CONNECTION WITH A REMANUFACTURED HANDPIECE OR LOSS OF INTEGRITY. NO BLEEDING INTRAOPERATIVELY BLEEDING SEEN HOURS POST OP. SITE OF BLEEDING NEVER IDENTIFIED. ADDITIONAL QUESTIONS ASKED OF SURGEON, BUT NOT RESPONSE: WHAT TECHNIQUE WAS USED WITH RESPECT TO THE ADVANCED HEMOSTASIS AND THE MIN/MAX BUTTON. DID YOU RECALL HEARING THE SECOND TONE WHEN USING THE ADVANCED HEMOSTASIS BUTTON? WHERE WAS THE ADVANCED HEMOSTASIS USED? WHERE WAS THE MIN/MAX BUTTON USED? WHAT OTHER INSTRUMENTS WERE USED DURING THE SURGERY? WAS THE BLEEDING ATTRIBUTED TO AN AREA WHERE THE HARMONIC +7 DEVICE WAS USED OR A STAPLER OR FACTOR? WHERE WAS THE BLEEDING FROM? HOW LONG HAVE YOU BEEN USING THE HARMONIC +7 DEVICE? WERE YOU IN-SERVICED PRIOR TO USING THE HARMONIC +7 DEVICE? DID THE GEN11 DISPLAY ANY YELLOW ALERT SCREENS DURING THE PROCEDURE? WHAT POWER SETTING WAS THE GENERATOR ON? WAS THE POWER LEVEL OF THE GENERATOR CHANGED TO ACHIEVE BETTER COAGULATION WHEN THE MILD BLEEDING OCCURRED? WHAT ARE YOUR TYPICAL STEPS TO USE THE DEVICE? (SUCH AS WAITING TO HEAR TONE 2, ETC.) PATIENT SPECIFIC QUESTIONS: WAS THE PATIENT TAKING ANY ANTICOAGULANTS, SUCH AS ASPIRIN, ANTICOAGULANTS, OR ANTIPLATELET AGENTS)? IF YES, SPECIFY PRESCRIBED MEDICATION. HAS THE PATIENT UNDERGONE ANY RADIATION/CHEMOTHERAPY THERAPY? IF YES, PLEASE SPECIFY RADIATION, CHEMO, OR BOTH. DOES THE PATIENT HAS A KNOWN COAGULATION DISORDER? HAS THE PATIENT TAKEN ANY STEROIDS? WHAT WAS THE TOTAL BLOOD LOSS? WHAT WAS THE PATIENT¿S PRE-OP HEMOGLOBIN AND HEMATOCRIT? WHAT WAS THE PATIENT¿S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? WHAT IS THE CURRENT PATIENT CONDITION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE IN WHICH THE DEVICE WAS USED, THE PATIENT CRASHED IN PACU, LOSING 4 LITERS OF BLOOD. THE PATIENT WAS GIVEN A TRANSFUSION OF 5000 CC OF BLOOD AND THE PATIENT IS CURRENTLY STABLE. NO ADDITIONAL INFORMATION WAS KNOWN. THE DEVICE WAS DISCARDED AS THERE WAS NO ISSUE WITH IT REPORTED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457818 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE