BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9507739 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24714
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    November 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. 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 STUDY TO COMPARE LYMPHOCELE AND LYMPHORRHEA CONTROL FOLLOWING INGUINAL AND AXILLARY THERAPEUTIC LYMPH NODE DISSECTION WITH OR WITHOUT THE USE OF AN ULTRASONIC SCALPEL. AUTHORS: MARIE-LAURE MATTHEY-GIE; OLIVIER GIE; SONA DERETTI; NICOLAS DEMARTINES; AND MAURICE MATTER. CITATION: ANN SURG ONCOL (2016) 23:1716¿1720; DOI 10.1245/S10434-015-5025-Y. THE AIMED OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY OF THE ULTRASONIC SCALPELS (USS) FOLLOWING THERAPEUTIC LYMPH NODE DISSECTION (TLND). BETWEEN MARCH 2009 AND NOVEMBER 2013, A TOTAL OF 80 PATIENTS WERE ENROLLED IN THE STUDY IN WHICH 40 PATIENTS (MALE=16, FEMALE=24; MEAN AGE=59.7 ± 15.1; MEAN BMI=25.5 ± 4.4 KG/M^2) WERE ASSIGNED TO USS GROUP AND 40 PATIENTS (MALE=16, FEMALE=24; MEAN AGE=61.9 ± 13.3; MEAN BMI=27.1 ± 5.1 KG/M^2) WERE ASSIGNED TO THE CONTROL (C) GROUP. THE DISSECTION CONDUCTED WITH THE USE OF USS GROUP WAS HARMONIC FOCUS (ETHICON). REPORTED COMPLICATIONS INCLUDED LYMPHOCELE (N=13); LYMPHATIC FISTULA (N=2); HEMATOMA (N=2); LYMPHEDEMA (N=20). IN CONCLUSION, THE USE OF USS FAILED TO OFFER ANY SIGNIFICANT REDUCTION IN LENGTH OF DRAIN USAGE AND OPERATIVE COMPLICATION, BUT IT SEEMS TO INCREASE THE RATE OF LYMPHEDEMA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294910 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other