BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9533418 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24807
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2013
    Report Date
    December 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2013. 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: ELECTROCAUTERY VERSUS ULTRACISION VERSUS LIGASURE IN SURGICAL MANAGEMENT OF HYPERHIDROSIS. AUTHOR : DUILIO DIVISI, V. FERRARI, A. DE VICO, G. IMBRIGLIO, W. DI FRANCESCANTONIO, M. VACCARILI, R. CRISCI. CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY; ABSTRACTS 21ST EUROPEAN CONFERENCE ON GENERAL THORACIC SURGERY BIRMINGHAM, UK, 26¿29 MAY 2013. THE AIM OF THE STUDY WAS TO EVALUATE THE SYMPATHECTOMY PROCEDURES FOR PRIMARY HYPERHIDROSIS IN TERMS OF COMPLICATIONS AND EFFECTIVENESS. FROM JAN 2010 TO SEP 2012, 65 PATIENTS (N=27 MALE AND N=38 FEMALE) WITH HYPERHIDROSIS UNDERWENT 130 SYMPATHECTOMIES USING THREE METHODS: ELECTROCOAGULATION (N=20), ULTRASONIC SCALPEL (N=54), AND RADIOFREQUENCY DISSECTOR (N=56). COMPLICATIONS IN ULTRASONIC SCALPEL GROUP INCLUDED CHEST PAIN (N=1) DISAPPEARED IN 20±1 DAY, AND BRADYCARDIA (N=1) WHICH NORMALIZED IN 4TH POSTOPERATIVE HOUR. THE LATEST GENERATION DEVICES OFFER GREATER EFFICACY IN THE TREATMENT OF HYPERHIDROSIS, MINIMIZING COMPLICATIONS AND FACILITATING THE RESUMPTION OF NORMAL WORK AND SOCIAL ACTIVITY OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323588 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other