BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9485234 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24475
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    January 1, 2012
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/17/2019. DATE OF EVENT: PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: TOTAL THYROIDECTOMY WITH ULTRASONIC SCALPEL: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL. AUTHORS: LUIZ P. KOWALSKI, PHD, ALVARO SANABRIA, PHD, JOSE´ GUILHERME VARTANIAN, PHD, ROBERTO ARAUJO LIMA, PHD, ULLIANOV BEZERRA TOSCANO DE MENDONCA, MD, CARLOS ROBERTO DOS SANTOS, MD, DOMINGOS BOLDRINI JÚNIOR, MD, LUIS EDUARDO BARBALHO DE MELLO, MD, FERNANDO PAIVA PINTO, MD, CARLOS NEUTZLING LEHN, PHD, LUIZ ARTUR COSTA CORREA, PHD, ROGÉRIO A. DEDIVITIS, PHD, ANDRE´ VICENTE GUIMARÃES, PHD, PAOLA ANDREA GALBIATTI PEDRUZZI, MSC, GYL HENRIQUE ALBRECHT RAMOS, PHD, ANTONIO JOSE´ GONCALVES, MD, ALEXANDRE BABÁ SUEHARA, MD, JOSSI LEDO KANDA, PHD, RENATO DE CASTRO CAPUZZO, MD, JOSE´ CARLOS DE OLIVEIRA, PHD MARIA PAULA CURADO, PHD, JOSE´ FRANCISCO DE GO´ IS FILHO, PHD,12 ERICA FUKUYAMA, PHD, IVO MARQUIS BESERRA JÚNIOR, MD, PAULO BENTES DE CARVALHO NETO, MD, ANDRE´ LOPES CARVALHO, PHD CITATION: PUBLISHED ONLINE: 2012 WILEY PERIODICALS, INC. HEAD NECK 34: 805¿812, 2012 DOI: 10.1002/HED.21815. THE OBJECTIVE OF THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL IS TO IMPROVE THE FLAWS OF PREVIOUS STUDIES BY DESIGNING A MULTICENTER RCT WITH A LARGE SAMPLE SIZE AND THE INCLUSION OF SAFETY AND ECONOMIC VARIABLES TO ASSESS THE EFFECTIVENESS OF ULTRASONIC SCALPELS IN TOTAL THYROIDECTOMY. A TOTAL OF 261 PATIENTS (241 FEMALES; 20 MALES) WERE RECRUITED FROM 11 HOSPITALS BETWEEN JANUARY 1, 2007 AND MARCH 5, 2008 TO PARTICIPATE IN THE STUDY. THE PATIENTS WERE RANDOMIZED TO THE EXPERIMENTAL GROUP WHICH INCLUDED PATIENTS (N=133) WHO UNDERWENT TOTAL THYROIDECTOMY WITH ULTRASONIC SCALPEL (HARMONIC, ETHICON), AND THE CONTROL GROUP WHICH INCLUDED PATIENTS (N=128) SUBMITTED TO CONVENTIONAL SURGERY. MEAN AGE (MEAN ± SD) FOR THE CONVENTIONAL GROUP WAS 48.8 ± 11.7 YEARS AND 47.9 ± 12.9 YEARS FOR THE HARMONIC GROUP. LIGATURE OF ANTERIOR JUGULAR VEIN (IF NEEDED), LIGATURE OF THE MEDIAN THYROID VEIN, AND DISSECTION OF THE UPPER AND INFERIOR POLE AND LIGATURE WERE PERFORMED USING ULTRASONIC SCALPEL. THE 2-DAY POSTOPERATIVE COMPLICATION IN THE HARMONIC GROUP IS HEMATOMA (N=1) WHILE THE 30-DAY POSTOPERATIVE COMPLICATIONS ARE THE FOLLOWING: HEMATOMA (N=1), SEROMA (N=6), POSTOPERATIVE UNILATERAL LARYNGEAL RECURRENT NERVE PARESIA (N=?), AND LARYNGOSCOPIC ABNORMALITIES DUE TO THYROIDECTOMY (N=?). HEMATOMA WAS TREATED WITH REOPERATION. IN CONCLUSION, THE AUTHORS REPORTED THAT THE USE OF AN ULTRASONIC SCALPEL WAS AS SAFE AS THAT OF THE CONVENTIONAL TECHNIQUE AND HAD THE ADVANTAGE OF A SHORTER OPERATIVE TIME AND LOWER POSTOPERATIVE DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272219 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1