BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9424148 · Received December 6, 2019

    Report

    Report Number
    3005075853-2019-24021
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/6/2019. DATE OF EVENT: PUBLICATION YEAR OF UNKNOWN. 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 : THE SAFETY OF ENERGY-BASED DEVICES IN OPEN THYROIDECTOMY: A PROSPECTIVE, RANDOMISED STUDY COMPARING THE LIGASURE¿ (LF1212) AND THE HARMONIC® FOCUS. AUTHOR : GIANLORENZO DIONIGI & LUIGI BONI & STEFANO RAUSEI & FRANCESCO FRATTINI & CESARE CARLO FERRARI & ALBERTO MANGANO & ANDREA LEOTTA & MARCO FRANCHIN. CITATION: LANGENBECKS ARCH SURG (2012) 397:817¿823; DOI 10.1007/S00423-011-0898-0. THIS PROSPECTIVE, RANDOMIZED STUDY AIMED TO COMPARE THE PERFORMANCES OF THE LF1212 AND FOCUS DEVICES IN OPEN THYROID SURGERY WITH AN EMPHASIS ON POSTOPERATIVE HYPOPARATHYROIDISM. A TOTAL OF 182 CONSECUTIVE PATIENTS SCHEDULED FOR OPEN THYROIDECTOMY WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMISED USING THE SEALED ENVELOPE METHOD INTO TWO SIMILARLY SIZED GROUPS: THE LIGASURE LF1212 THYROIDECTOMY GROUP (L GROUP) (N=90) AND THE HARMONIC FOCUS GROUP (F GROUP) (N=92) [N=75 FEMALES N=17 MALES, MEAN AGE: 40.8 YEARS, RANGE: 20-79 YEARS, MEAN BMI 26 KG/M2]. A STANDARDISED APPROACH TO THE THYROID GLAND WAS PERFORMED WHEN USING EITHER STUDY DEVICE: THE UPPER PEDICLE, THE MIDDLE VEIN AND THE INFERIOR THYROID VESSELS WERE LIGATED WITH THE LIGASURE LF1212 OR THE HARMONIC FOCUS (ETHICON). BOTH DEVICES WERE USED TO DIVIDE THE THYROID TISSUE OF THE ISTHMUS INTO HEMITHYROIDECTOMIES, TO ISOLATE THE GLAND FROM THE TRACHEA AND TO ISOLATE THE PYRAMIDAL LOBE FROM THE LARYNX. COMPLAINTS INCLUDED SEROMA (N=1), UNINTENDED WOUND BURN (N=1), PERMANENT HYPOPARATHYROIDISM (N=1), TEMPORARY RLN INJURY (N=6). THE RESULTS OF THIS STUDY DEMONSTRATED NO SIGNIFICANT DIFFERENCE IN THE RATES OF POSTOPERATIVE MORBIDITY ASSOCIATED WITH THESE TWO DIFFERENT EBDS USED. DIFFERENCES IN CLINICALLY LESS SIGNIFICANT WERE FOUNDED AND FOCUSED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222040 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability