BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9412776 · Received December 4, 2019

    Report

    Report Number
    3005075853-2019-23968
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    January 1, 2013
    Report Date
    November 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. 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: THE USE OF THE HARMONIC SCALPEL VERSUS KNOT TYING FOR MODIFIED RADICAL NECK DISSECTION. AUTHOR: ORHAN AGCAOGLU, MD1, SHAMIL ALIYEV, MD1, JAMIE MITCHELL, MD1, MIRA MILAS, MD, ALLAN SIPERSTEIN, MD, AND EREN BERBER, MD. CITATION: SURGICAL INNOVATION 20(1) 81¿ 85; 2013; DOI: 10.1177/1553350612444782. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT THE USE OF THE HARMONIC SCALPEL VERSUS KNOT TYING FOR MODIFIED RADICAL NECK DISSECTION (MRND). BETWEEN JANUARY 2000 AND DECEMBER 2010, 119 PATIENTS UNDERWENT MODIFIED LATERAL NECK DISSECTION FOR THYROID CANCER. A TOTAL OF 24 PATIENTS (MALE= 10, FEMALE= 14; AGE RANGE= 49.2 ± 3.9 YEARS; BMI RANGE=2 9 ± 1 KG/M^2) WERE UNDER UNILATERAL MRND USING HARMONIC SCALPEL (HS) (ETHICON) AND 23 PATIENTS (MALE= 8, FEMALE= 15; AGE RANGE= 55 ± 4.2 YEARS; BMI RANGE= 30 ± 1 KG/M^2) WERE IN KNOT-TYING. REPORTED COMPLICATION FOR HARMONIC GROUP INCLUDED LYMPHATIC LEAKS (N=2) WHICH REQUIRED A SECOND OPERATION FOR REPAIR. IN CONCLUSION, DESPITE THE LIMITATIONS OF ITS RETROSPECTIVE NATURE, THIS STUDY SHOWS THAT THE HS REDUCES ESTIMATED BLOOD LOSS AND THE AMOUNT OF LYMPHATIC DRAINAGE COMPARED TO KNOT TYING AFTER MRND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205425 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1