BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9475716 · Received December 16, 2019

    Report

    Report Number
    3005075853-2019-24376
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    January 1, 2014
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2014. 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: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL: COMPARISON OF TWO DIFFERENT METHODS OF HEPATECTOMY. AUTHOR/S: SUN HANYONG, LAU WANYEE, FU SIYUAN, LI HUI, YANG YUAN, LIN CHUAN, ZHOU WEIPING, WU MENGCHAO. CITATION: EJSO 41 (2015) 243-248; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJSO.2014.10.057. THIS RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE THE PERIOPERATIVE OUTCOMES OF PARTIAL HEPATECTOMY USING EITHER FINGER FRACTURE OR CLAMP CRUSHING TECHNIQUE WITH PRINGLE MANEUVER (PM) OR HARMONIC SCALPEL (HS) WITHOUT HEPATIC VASCULAR INFLOW OCCLUSION. FROM JAN2012 TO SEP2012, 160 PATIENTS UNDERWENT PARTIAL HEPATECTOMY FOR LIVER TUMORS AND WERE RANDOMLY ASSIGNED INTO TWO GROUPS: PM (N=80; N=62 MALE AND N=18 FEMALE; MEAN AGE OF 52.0±10.6 YEARS) AND HS (N=80; N=58 MALE AND N=22 FEMALE; MEAN AGE OF 52.3±9.7 YEARS). FOR THE HS GROUP, LIVER RESECTION WAS CARRIED OUT WITHOUT HEPATIC VASCULAR OCCLUSION. THE HARMONIC SCALPEL (ETHICON ENDO-SURGERY, JOHNSON & JOHNSON, NEW JERSEY, USA) WAS SET AT A HIGH POWER, AND BLOOD VESSELS OR BILE DUCTS UP TO 3E4 MM IN DIAMETER WERE COAGULATED FOR 5-6 S. BLOOD LOSS REQUIRING TRANSFUSION WAS REPORTED IN 4 PATIENTS IN HS GROUP. OVERALL COMPLICATIONS IN HS GROUP INCLUDED BILE LEAK (N=3) AND SINGLE ORGAN DYSFUNCTION GRADE IV (N=2). THE USE OF HARMONIC SCALPEL HAS BEEN REPORTED TO HAVE A SIGNIFICANTLY HIGHER INCIDENCE OF POST-OPERATIVE BILE LEAK. THE RESULTS INDICATED THAT LIVER RESECTION CARRIED OUT USING HS WITHOUT HEPATIC VASCULAR INFLOW OCCLUSION WAS BETTER THAN THE FINGER FRACTURE OR CLAMP CRUSHING TECHNIQUE USING PRINGLE MANEUVER. THE USE OF HS ALLOWED LIVER RESECTION TO BE SAFELY PERFORMED, WITH THE ADVANTAGES OF A LOW SURGICAL COMPLICATION RATE AND LESS BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271640 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention