BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9556130 · Received January 6, 2020

    Report

    Report Number
    3005075853-2020-00015
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    January 1, 2012
    Report Date
    December 9, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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 : SAFETY AND COST-EFFECTIVENESS IN THYROIDECTOMY USING THE HARMONIC SCALPEL COMPARED TO TRADITIONAL HEMOSTASIS: A CONTROLLED CLINICAL ASSAY. AUTHOR : ERICH O.P. BASURTO-KUBA, MD, FACS, MAYBELLINE ROBLES-ESTRADA, MD, CARLOS CAMPOS-CASTILLO, MD, MSC, LUISMAURICIO HURTADO-LÓPEZ, MD, PHD, FELIPE RAFAEL ZALDÍVAR-RAMÍREZ, MD, MSC, , ABRAHAM PULIDO-CEJUDO , MD, MSC. CITATION: SURGICAL TECHNOLOGY INTERNATIONAL VOLUME 30. THE AIM OF THIS CLINICAL CONTROL TRIAL WAS TO ANALYZE THE COST-EFFECTIVENESS AND TO UNDERSTAND THE EFFICACY OF THE HARMONIC SCALPEL SYSTEM WITH FOCUS®+ SHEARS (ETHICON INC., SOMERVILLE, NEW JERSEY) AS THE ONLY SYSTEM TO CUT AND COAGULATE IN THYROIDECTOMY. DURING THE MONTHS OF APRIL TO SEPTEMBER OF 2012, 100 PATIENTS UNDERGOING THYROID SURGERY WERE DIVIDED INTO TWO RANDOMIZED GROUPS: IN GROUP 1, THE HARMONIC DEVICE WAS THE ONLY DEVICE USED FOR CUT AND COAGULATE (N=50; N=48 FEMALE AND N=2 MALE; AVERAGE AGE OF 48.28 YEARS [RANGED 98-85 YEARS]); AND IN GROUP 2, CLAMP, TIE AND ELECTROCAUTERY WERE USED (N=50; N=48 FEMALE AND N=2 MALE; AVERAGE AGE OF 45.24 YEARS [RANGED 18-78 YEARS]). IN GROUP 1, INTRAOPERATIVE HEMORRHAGE WAS REPORTED IN 9 PATIENTS AND REQUIRED RESCUE WITH LIGATION. ALL OF THEM WERE DETECTED AND NO CASE EXPERIENCED BLEEDING SUBSEQUENT TO THE SURGERY. ANOTHER POINT WHICH BEARS UNDERSCORING IS THAT IN GROUP 1, THERE WAS A HEMOSTASIS FAILURE, MEANING THAT THE DEVICE WAS APPLIED ACCORDING TO THE MANUFACTURER¿S STANDARDS; HOWEVER, THE PROPER SEALING WAS NOT OBTAINED, AND IT WAS PREFERRED, BY PROTOCOL, TO LIGATE THOSE VESSELS. WE CONCLUDE THAT THE UTILIZATION OF THE FOCUS®+ DEVICE IS SIMILAR TO THE TRADITIONAL TECHNIQUE OF LIGATURE AND KNOTS AS FAR AS COST-EFFECTIVENESS IS CONCERNED, DUE TO THE FACT THAT THE GREATER EXPENSE OF THE DEVICE IS COMPENSATED BY THE LOWER EXPENSE IN TIME AND SURGICAL RE-INTERVENTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12621 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1