BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9478681 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24429
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/16/2019. 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: MODIFIED RADICAL MASTECTOMY: A PILOT CLINICAL TRIAL COMPARING THE USE OF CONVENTIONAL ELECTRIC SCALPEL AND HARMONIC SCALPEL AUTHORS: GUSTAVO HENRIQUE FABRI PEREIRA RIBEIRO, LIGIA MARIA KERR, RAPHAEL LUIZ HAIKEL, STELA VERZINHASSE PERES, ANGELO GUSTAVO ZUCCA MATTHES, RODRIGO AUGUSTO DEPIERI MICHELLI, ANTÔNIO BAILÃO JR., JOSÉ HUMBERTO TAVARES GUERREIRO FREGNANI AND RENÉ ALOÍSIO DA COSTA VIEIRA. CITATION: INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 496-500; HTTP://DX.DOI.ORG/10.1016/J.IJSU.2013.03.013. THIS PROSPECTIVE NON-RANDOMISED CLINICAL TRIAL AIMED TO COMPARE THE RATES OF LOCAL POSTOPERATIVE COMPLICATIONS AMONG WOMEN UNDERGOING MODIFIED RADICAL MASTECTOMY WITH AN ELECTRIC SCALPEL (ES) OR A HARMONIC SCALPEL (HS). BETWEEN APRIL AND DECEMBER 2008, FORTY-SIX FEMALE PATIENTS (MEDIAN AGE 53.5, 31-82 YEARS) UNDERWENT A MRM WITH AN ELECTRIC SCALPEL (ES) CALIBRATED AT 40 WATTS OF CUTTING AND COAGULATION POWER AND 49 FEMALE PATIENTS (MEDIAN AGE 58.0, RANGE 27-80 YEARS) WITH HARMONIC SCALPEL (HS) (HARMONIC WITH A GEN04 GENERATOR FROM ETHICON ENDO-SURGERY, (B)(4), USA), CALIBRATED AT POWER LEVELS 3 AND 5 USING THE HP054 HAND PIECE AND HF105 CURVED BLADE. COMPLICATIONS INCLUDED SEROMA (N=8), NECROSIS (N=2), INFECTION (N=1) AND HAEMATOMA (N=1). IN CONCLUSION, HSS DO NOT DECREASE THE SEROMA RATE. HOWEVER, THIS METHOD MAY BE USEFUL IN SKIN SPARING MASTECTOMY BECAUSE IT DECREASES SKIN FLAP NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273537 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other