BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9490701 · Received December 18, 2019

    Report

    Report Number
    3005075853-2019-24518
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    January 1, 2012
    Report Date
    November 22, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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 : MONOPOLAR ELECTROCAUTERY VERSUS ULTRASONIC DISSECTION OF THE GALLBLADDER FROM THE GALLBLADDER. BED IN LAPAROSCOPIC CHOLECYSTECTOMY: A RANDOMIZED CONTROLLED TRIAL. AUTHOR : VARUN MAHABALESHWAR, , LILESWAR KAMAN, JAVID IQBAL, , RAJINDER SINGH, MS. CITATION: DOI: 10.1503/CJS.000411. THE PRESENT STUDY WAS DESIGNED AND CONDUCTED TO OBSERVE THE EFFECT OF ULTRASONIC DISSECTION IN LAPAROSCOPIC CHOLECYSTECTOMY AND TO DETERMINE THE INCIDENCE OF GALLBLADDER PERFORATION AND ITS INTRAOPERATIVE CONSEQUENCES. BETWEEN JAN2009 AND DEC2009, 60 ADULT PATIENTS WITH SYMPTOMATIC GALLSTONE DISEASE WHO UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND WERE RANDOMLY ASSIGNED USING THE ENVELOPE METHOD TO EITHER MONOPOLAR ELECTROCAUTERY (N=30; MALE:FEMALE RATIO OF 1:1.5; MEAN AGE OF 47.36 YEARS) OR ULTRASONIC DISSECTION (N=30; MALE:FEMALE RATIO OF 1:2.75; MEAN AGE OF 45.3 YEARS) JUST BEFORE THE OPERATION. IN THE ULTRASONIC DISSECTION GROUP, DISSECTION OF THE GALLBLADDER WAS PERFORMED USING HARMONIC ACE CURVED SHEARS (ETHICON ENDO-SURGERY, JOHNSON & JOHNSON CO.). IN ULTRASONIC GROUP, COMPLICATION INCLUDED GALLBLADDER PERFORATION (N=5), BILE LEAK (N=5), AND STONE SPILLAGE (N=2). ULTRASONIC DISSECTION IS SAFE AND EFFECTIVE, AND IT IMPROVES THE OPERATIVE COURSE OF LAPAROSCOPIC CHOLECYSTECTOMY. IT PROVIDES A SUPERIOR ALTERNATIVE TO THE CURRENTLY USED HIGH FREQUENCY MONOPOLAR TECHNOLOGY IN TERMS OF A LOWER INCIDENCE OF GALLBLADDER PERFORATION, ESPECIALLY IN PATIENTS WITH COMPLICATED GALLBLADDER DISEASE, AND A SHORTER DURATION OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286442 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention