BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9505680 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24571
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2009
    Report Date
    November 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. 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: USE OF THE HARMONIC SCALPEL IN THYROIDECTOMY. AUTHOR: DAVID J. PARKER, KATHERINE KRUPA, RACHEL ESLER, PETER VUJOVIC AND IAN C. BENNETT. CITATION: ANZ J SURG 79 (2009) 476¿480; DOI: 10.1111/J.1445-2197.2009.04949.X. THIS STUDY AIMED TO DEMONSTRATE THE SAFETY AND EFFICACY OF THE HARMONIC SCALPEL IN THYROID SURGERY, ITS USE OVER AN APPROXIMATE 2-YEAR PERIOD BY TWO SURGEONS FROM OUR INSTITUTION WAS ANALYSED PROSPECTIVELY AND COMPARED TO A SIMILAR 2-YEAR COHORT OF RETROSPECTIVE DATA FROM THE PRE-HARMONIC SCALPEL ERA. FROM 2004 TO 2005, 88 PATIENTS UNDERWENT THYROID OPERATIONS USING THE HARMONIC SCALPEL WHICH WERE RETROSPECTIVELY ANALYSED WITH A COHORT OF 57 PATIENTS UNDERGOING THYROID SURGERY USING CONVENTIONAL TECHNIQUES FROM 1998 TO 1999. IN PATIENTS UNDER HARMONIC SCALPEL, THE PATIENTS WERE OPERATED USING THE SHORT HANDLE (14CM) HARMONIC SCALPEL COAGULATING SHEARS (HARMONIC SCALPEL SYSTEM). IN THE HARMONIC SCALPEL GROUP, COMPLICATIONS INCLUDED HAEMATOMA (N=1) REQUIRING RETURN TO THEATRE WITHIN 24 HOURS; TRANSIENT HYPOCALCEMIA (N=12); AND TEMPORARY RLN INJURY (N=2). HARMONIC SCALPEL USE WAS NOT ASSOCIATED WITH AN INCREASED COMPLICATION RATE AND HAS BEEN DEMONSTRATED TO BE A VERY EFFICIENT AND SAFE TOOL IN ASSISTING WITH THE CONDUCT OF A THYROIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295412 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention