BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9511369 · Received December 23, 2019

    Report

    Report Number
    3005075853-2019-24737
    Event Type
    Injury
    Date Received
    December 23, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2015. 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

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE, TITLE: LYMPHATIC COMPLICATIONS CONTROL FOLLOWING INGUINAL AND AXILLARY RADICAL LYMPH NODE DISSECTION: A RANDOMIZED CONTROLLED TRIAL. AUTHOR: MATTHEY-GIE M.-L; GIE O; DERETTI S.; DEMARTINES N.; MATTER M. CITATION: EUROPEAN JOURNAL OF LYMPHOLOGY AND RELATED PROBLEMS. CONFERENCE: 41ST EUROPEAN SOCIETY OF LYMPHOLOGY CONGRESS, ESL 2015. SWITZERLAND. 26 (72) (PP 18), 2015. THIS RANDOMIZED CONTROLLED TRIAL AIMED TO EVALUATE THE EFFICACY OF THE HARMONIC SCALPEL FOR RADICAL LYMPH NODE DISSECTION (RLND). BETWEEN 2009 AND 2013, A TOTAL OF 80 PATIENTS UNDERGOING INGUINAL OR AXILLARY RLND OR COMPLETION LYMPH NODE DISSECTION AFTER POSITIVE SENTINEL LYMPH NODE BIOPSY (SLNB) FOR MELANOMA OR SARCOMA WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY ASSIGNED IN GROUP HS (DISSECTION WAS CONDUCTED WITH HARMONIC SCALPEL (ETHICON)) (N=40) AND GROUP C (DISSECTION WAS CONDUCTED BY LIGATION AND MONOPOLAR ELECTROCAUTERY). COMPLAINT INCLUDED LYMPHOEDEMA (DEFINED AS AN INCREASED CIRCUMFERENCE OF THE OPERATED LIMB OF MORE THAN 10%) (N= 50%), LYMPHATIC FISTULA (N=5%), LYMPHOCOELE (N=32.5%), AND HEMATOMA (N=5%). IN CONCLUSION, THE USE OF HARMONIC SCALPEL FAILED TO OFFER A SIGNIFICANT REDUCTION FOR LENGTH OF DRAINAGE AND OPERATIVE COMPLICATION, EVEN AN INCREASED RATE OF LYMPHOEDEMA WAS OBSERVED. THUS, TRADITIONAL SURGICAL MANAGEMENT CAN BE USED SAFELY IN RLND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305341 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other