BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9490740 · Received December 18, 2019

    Report

    Report Number
    3005075853-2019-24519
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    January 1, 2009
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. 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: INCIDENCE OF ARM LYMPHOEDEMA FOLLOWING SENTINEL NODE BIOPSY, AXILLARY SAMPLING AND AXILLARY DISSECTION IN PATIENTS WITH BREAST CANCER. AUTHOR : FRANCO LUMACHI, STEFANO M.M. BASSO, MANUELA BONAMINI, FILIPPO MARINO, BERNARDO MARZANO, ELISA MILAN, BEATA U. WACLAW AND GIORDANO B. CHIARA. CITATION: IN VIVO 23: 1017-1020 (2009). THE AIM OF THIS STUDY WAS TO COMPARE THE INCIDENCE OF LYMPHOEDEMA AFTER DIFFERENT TREATMENTS OF THE AXILLA IN PATIENTS WITH BREAST CANCER BC. A TOTAL OF 205 PATIENTS (MEDIA AGE OF 61 YEARS [RANGED 26-72 YEARS]) WITH BREAST CANCER UNDERWENT CURATIVE SURGERY. ACCORDING TO THE TREATMENT OF THE AXILLA, THE STUDY POPULATION WAS DIVIDED INTO FOUR AGE- AND STAGE-MATCHED GROUPS OF PATIENTS: GROUP A (N=54 PATIENTS; MEAN AGE OF 59.2±12.3 YEARS), SENTINEL NODE BIOPSY (SLNB) ALONE; GROUP B (N=48 PATIENTS; MEAN AGE OF 58.7±13.6 EARS), SLNB FOLLOWED BY AXILLARY NODE (AN) SAMPLING USING ULTRASOUND SCISSORS (HARMONIC SCALPEL); GROUP C (N=53 PATIENTS; MEAN AGE OF 60.7±13.2 YEARS), AN DISSECTION USING ULTRASOUND SCISSORS; AND GROUP D (N=50 PATIENTS; MEAN AGE OF 61.3±13.4 YEARS), TRADITIONAL AN DISSECTION. AT FOLLOW-UP, LYMPHOEDEMA WAS REPORTED IN GROUP B (N=2). IN CONCLUSION, AN SAMPLING IS A SENSITIVE AND LOW-MORBIDITY PROCEDURE USEFUL IN REDUCING THE FALSE-NEGATIVE RESULTS OF SLNB ALONE. THE USE OF HARMONIC SCALPEL MAY REDUCE THE ONSET OF ARM LYMPHOEDEMA, ESPECIALLY WHEN ALND IS REQUIRED, ALTHOUGH ITS REAL USEFULNESS IS STILL UNDER DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286484 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other