BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 3872114 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03976
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REQUESTED: WHAT WAS USED AS THE PRIMARY MEANS OF HEMOSTASIS FOR RIGHT SUPERIOR THYROID ARTERY OF OTHER METHODS USED IN CONJUNCTION JUST AS SUTURE? IN 2ND PROCEDURE, WAS SITE IDENTIFIED AND WAS THIS AN AREA WERE FCS9 USED? ANY ISSUES WITH BLOOD PRESSURE DURING OR AFTER SURGERY? DOES THE SURGEON USE SUTURES/CLIPS TO TIE OFF THE VESSELS OR DID THE SURGEON ONLY USE THE FCS9 FOR THE ENTIRE PROCEDURE? WHAT DISPOSABLE(S) WAS BEING USED? WHAT OTHER INSTRUMENTS WERE USED DURING THE SURGERY? IF THE SURGEON DID USE SUTURES OR CLIPS BESIDES THE FCS9, WAS THE BLEEDING FROM THE VESSEL WHERE THE FCS9 WAS USED? HAD THE PATIENT COUGHED PRIOR TO THE BLEEDING? WHAT DID THE PATIENT PRESENT WITH, THAT RESULTED IN GOING BACK TO THE OR? (NECK SWELLING, NECK PAIN, AND/OR SIGNS AND SYMPTOMS OF AIRWAY OBSTRUCTION E.G., DYSPNEA, STRIDOR, HYPOXIA). HOW WAS THE BLEEDING CONTROLLED IN THE SECOND PROCEDURE? HOW MUCH BLOOD WAS LOST? DID THE PATIENT REQUIRE A TRANSFUSION? 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 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 AFTER A TOTAL THYROIDECTOMY PROCEDURE, ABOUT A MONTH AGO I HAD A MAJOR POST-OP BLEEDING EPISODE FROM THE RIGHT SUPERIOR THYROID ARTERY IN A GRAVES DISEASE PATIENT WHO HAD UNDERGONE A TOTAL THYROIDECTOMY. THE HARMONIC WAS USED. THE BLEED OCCURRED ABOUT ONE HOUR POST-OP IN THE PACU AND REQUIRED IMMEDIATE OPENING OF THE WOUND AND THEN RE-EXPLORATION IN THE OR. IT WAS A NEAR CATASTROPHE. THE ARTERY WAS PUMPING BRISKLY. FORTUNATELY, THE PATIENT DID WELL THEREAFTER. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349343 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE