BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9476953 · Received December 16, 2019

    Report

    Report Number
    3005075853-2019-24401
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    January 1, 2008
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. 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 : USE OF THE HARMONIC SCALPEL VERSUS CONVENTIONAL HAEMOSTATIC TECHNIQUES IN PATIENTS WITH GRAVE DISEASE UNDERGOING TOTAL THYROIDECTOMY: A PROSPECTIVE RANDOMISED CONTROLLED TRIAL. AUTHOR : P. HALLGRIMSSON & L. LOVÉN & J WESTERDAHL & ANDERS BERGENFELZ. CITATION: LANGENBECKS ARCH SURG (2008) 393:675¿680; DOI 10.1007/S00423-008-0361-Z. THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE THE USE OF THE HARMONIC SCALPEL WITH CONVENTIONAL TECHNIQUES IN A HOMOGENOUS GROUP OF PATIENTS WITH GRAVES¿ DISEASE. BETWEEN NOVEMBER 2003 TO MAY 2006, 51 PATIENTS WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMIZED TO EITHER TOTAL THYROIDECTOMY WITH THE USE OF THE HARMONIC SCALPEL ¿ HS GROUP (MALE=9, FEMALE=18; MEAN AGE=42 YEARS, AGE RANGE=20-70 YEARS) OR TOTAL THYROIDECTOMY WITH CONVENTIONAL HAEMOSTATIC TECHNIQUES ¿ CONVENTIONAL GROUP (MALE=3, FEMALE=21; MEAN AGE=34 YEARS, AGE RANGE=20-59 YEARS). DURING THE PROCEDURE, ULTRACISION HARMONIC SCALPEL (ETHICON) WAS USED FOR CUTTING AND COAGULATION. REPORTED COMPLICATIONS IN HS GROUP INCLUDED TRANSIENT RECURRENT NERVE PARESIS (N=4). IN CONCLUSION, THE USE OF THE HS WAS ASSOCIATED WITH A SIGNIFICANT REDUCTION IN OPERATING TIME COMPARED TO THE USE OF THE CONVENTIONAL HAEMOSTATIC TECHNIQUES IN PATIENTS WITH GRAVES¿ DISEASE UNDERGOING TOTAL THYROIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271680 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1