BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9505051 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24588
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 1, 2008
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. 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 : LIGASURE VERSUS ULTRACISION® IN THYROID SURGERY: A PROSPECTIVE RANDOMIZED STUDY. AUTHOR : PAOLA VINCENZA SARTORI & SERGIO DE FINA & GIOVANNI COLOMBO & FRANCESCO PUGLIESE & FABRIZIO ROMANO & GIOVANNI CESANA & FRANCO UGGERI. CITATION: LANGENBECKS ARCH SURG (2008) 393:655¿658 / DOI 10.1007/S00423-008-0386-3. THE AIM OF THIS PROSPECTIVE RANDOMIZED STUDY IS TO COMPARE CONVENTIONAL TYING AND KNOTS, LIGASURE, AND HARMONIC SCALPEL IN TOTAL THYROIDECTOMY, IF ONE OF THEM HAS A REAL ADVANTAGE OVER THE OTHERS. FROM JAN 1ST 2007 THROUGH JUNE 30TH 2007, A TOTAL OF 150 PATIENTS (N=27 MALES, N=123 FEMALE, MEAN AGE 56±14 YEARS), WITH BENIGN OR MALIGNANT THYROID DISEASE UNDERWENT TOTAL THYROIDECTOMY. THE PATIENTS WERE RANDOMIZED INTO THREE GROUPS ACCORDING TO THE HEMOSTATIC TECHNIQUE: CONVENTIONAL TECHNIQUE OF TYING AND KNOTS (CT) (N=50), LIGASURE VESSEL SEALING SYSTEM (LI) (N=50) OR HARMONIC SCALPEL (HS) (ULTRACISION, ETHICON ENDOSURGERY) (N=50). IN THE HS GROUP, THE HARMONIC SCALPEL WAS ALWAYS USED AND THE RESULTING THYROIDECTOMY WAS SUTURELESS. POSTOPERATIVE COMPLICATIONS INCLUDED HEMORRHAGE (N=1); AND HYPOCALCAEMIA (N=30) WHICH RECEIVED ORAL CALCIUM CARBONATE AND VITAMIN D3 SUPPLEMENTATION. THE ONLY REAL ADVANTAGE OF NEW HEMOSTATIC TECHNOLOGIES WAS A SHORTER OPERATION TIME WITH HS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298780 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention