BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9491266 · Received December 18, 2019

    Report

    Report Number
    3005075853-2019-24525
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    January 1, 2010
    Report Date
    November 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2010. MEDICAL DEVICE: 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: PROSPECTIVE RANDOMIZED TRIAL OF LIGASURE VERSUS HARMONIC HEMOSTASIS TECHNIQUE IN THYROIDECTOMY. AUTHOR/S: REZA RAHBARI, MD, AARTI MATHUR, MD, MIO KITANO, MD, MARLON GUERRERO, MD, WEN T. SHEN, MD, QUAN-YANG DUH, MD, ORLO H. CLARK, MD, AND ELECTRON KEBEBEW, MD. CITATION: ANN SURG ONCOL (2011) 18:1023¿1027; DOI 10.1245/S10434-010-1251-5. THIS SINGLE-BLINDED PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AIMED TO DETERMINE IF THERE WAS A DIFFERENCE IN OPERATIVE TIME OR COST OF THYROIDECTOMY (OPERATIVE AND TOTAL) BETWEEN THE TWO SURGICAL DEVICES INDEPENDENT OF THE PROCEDURE AND THYROID DISEASE TYPE; AND TO DETERMINE IF THERE WAS A DIFFERENCE IN COMPLICATION RATES BETWEEN THE TWO SURGICAL DEVICES. FROM OCT2007 TO JAN2009, 90 PATIENTS WITH THYROID CANCER, THYROID NODULE OR HYPERTHYROIDISM UNDERWENT THYROIDECTOMY, AND WERE RANDOMIZED TO EITHER BIPOLAR SEALING SYSTEM (B) GROUP (N=45; N=9 MALE AND N=36 FEMALE; MEAN AGE OF 48.7 YEARS) OR ULTRASONIC COAGULATION (UC) GROUP (N=9 MALE AND N=36 FEMALE; 46.1 YEARS). IN UC, VESSEL LIGATION WAS ACCOMPLISHED USING HARMONIC FOCUS SINGLE USE HAND PIECE. IN UC GROUP MINOR COMPLICATIONS INCLUDED PERIORAL NUMBNESS (N=?) AND TRANSIENT VOICE CHANGES (N=?). IN SUMMARY, WE FOUND NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE OPERATIVE TIME OR COST OF THYROIDECTOMY BETWEEN THE TWO SURGICAL DEVICES. WE ALSO FOUND NO DIFFERENCE IN MAJOR OR MINOR COMPLICATIONS BETWEEN THE TWO DEVICES. THERE WAS A STATISTICALLY SIGNIFICANT DIFFERENCE IN TOTAL COST BETWEEN SURGEONS INDEPENDENT OF DEVICE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286445 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1