BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC 5MM LAP SHEARS

    MDR report key: 9674033 · Received February 5, 2020

    Report

    Report Number
    3005075853-2020-00781
    Event Type
    Injury
    Date Received
    February 5, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2005. 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: LAPAROSCOPIC LYMPHADENECTOMY FOR GYNECOLOGIC MALIGNANCIES USING ULTRASONICALLY ACTIVATED SHEARS: ANALYSIS OF FIRST 100 CASES. AUTHORS: FARR NEZHAT, JYOTI YADAV, JAMAL RAHAMAN, HERBERT GRETZ III, GINGER J. GARDNER, CARMEL J. COHEN. CITATION: GYNECOLOGIC ONCOLOGY 97 (2005) 813¿819. DOI:10.1016/J.YGYNO.2005.02.005. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE USE OF ULTRASONIC SHEARS IN PERFORMING LAPAROSCOPIC LYMPHADENECTOMY IN A LARGER COHORT OF PATIENTS AT A SINGLE INSTITUTION. THIS PROSPECTIVE STUDY INVOLVES 100 PATIENTS (MEDIAN AGE: 58 YEARS; AGE RANGE: 17-87 YEARS) WHO UNDERWENT LAPAROSCOPIC LYMPHADENECTOMY BETWEEN JANUARY 1999 AND APRIL 2004. ULTRASONIC SHEARS (LCS5, ETHICON) WAS USED AS THE INSTRUMENT FOR DISSECTION AND HEMOSTASIS. REPORTED COMPLICATIONS INCLUDED SIGNIFICANT BLOOD LOSS (N-?), INJURY TO A BRANCH OF THE INFERIOR MESENTERIC ARTERY (N-?) WHICH WAS CONTROLLED WITH BIPOLAR FORCEPS, AND INJURY TO THE RIGHT HYPOGASTRIC VEIN DURING LAPAROSCOPIC PELVIC LYMPHADENECTOMY (N-?) WHICH WAS MANAGED WITH HEMOSTATIC CLIPS. THIS IS THE LARGEST SERIES TO DATE DEMONSTRATING THE SAFETY AND EFFICACY OF ULTRASONIC SHEARS IN LAPAROSCOPIC LYMPHADENECTOMY FOR GYNECOLOGIC MALIGNANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133154 HARMONIC 5MM LAP SHEARS INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other