BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9345059 · Received November 19, 2019

    Report

    Report Number
    3005075853-2019-23597
    Event Type
    Injury
    Date Received
    November 19, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    TITLE : ADVANCED HEMOSTASIS IN AXILLARY LYMPH NODE DISSECTION FOR LOCALLY ADVANCED. BREAST CANCER: NEW TECHNOLOGY DEVICES COMPARED IN THE PREVENTION OF SEROMA FORMATION. AUTHOR : CLAUDIO GAMBARDELLA , GUGLIELMOCLARIZIA, RENATOPATRONE, CHIARAOFFI, CLAUDIOMAURIELLO1, ROBERTOROMANO, MARCO FILARDO, ALESSANDRACONZO, ALESSANDROSANGUINETTI2, ANDREAPOLISTENA2, NICOLAAVENIA2 AND GIOVANNICONZO. CITATION: GAMBARDELLA ET AL.BMC SURGERY 2019, 18(SUPPL 1):125; DOI: HTTPS://DOI.ORG/10.1186/S12893-018-0454-8. THE AIM OF THE STUDY IS TO COMPARE THE DIFFERENT HAEMOSTASIS DEVICES USED IN BREAST SURGERY, INVESTIGATING THE EVENTUAL SUPERIORITY OF AN INSTRUMENT AMONG THE OTHERS IN TERMS OF INTRAOPERATIVE AND POSTOPERATIVE OUTCOME,ESPECIALLY OF SEROMA FORMATION. BETWEEN JAN2013 AND JUL2017, 100 CONSECUTIVE FEMALE PATIENTS UNDERWENT AXILLARY LYMPH NODE DISSECTION FOR BREAST CANCER AND WERE RETROSPECTIVELY ASSIGNED INTO FOUR GROUPS ACCODING TO DEVICE UTILIZED DURING SURGERY: ELECTROCAUTERY (N=25), HARMONIC SCALPEL (N=25), LIGASURE (N=25), AND THUNDERBEAT (N=25). ALL PROCEDURES WERE PERFORMED BY THE SAME EQUIP EXPERIENCED IN BREAST SURGERY ACCORDING TO STANDARDIZED SURGICAL TECHNIQUE. IN HARMONIC SCALPEL GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED SEROMA (N=6) AND N=LYMPHEDEMA (N=2). NOWADAYS DEFINITIVE ETIOLOGY AND PATHOPHYSIOLOGY OF SEROMA FORMATION ARE STILL UNKNOWN, DESPITE DIFFERENT HYPOTHESIS WERE EXPRESSED, SUCH AS ACUTE INFLAMMATORY REACTION FOLLOWING SURGICAL TRAUMA, RESPONSE TO INCREASED FIBRINOLYTIC ACTIVITY IN SERUM AND LYMPH, REDUCTION OF FIBRINOGEN LEVELS IN PLASMA. PATIENT¿S HIGH BODY MASS INDEX, HYPERTENSION, PREOPERA- TIVE RADIATION, TUMOR SIZE, EXTENDED BREAST SURGERY, EXTENDED AXILLARY LYMPH NODE INVOLVEMENT AND THEUSE OF ELECTROCAUTERY HAVE ALL BEEN RELATED TO SEROMA FORMATION. IN PATIENTS AFFECTED BY BREAST CANCER REQUIRING AXILLARY LYMPH NODES DISSECTION, THE USE OF ADVANCED HEMOSTASIS DEVICES IS HIGHLY DESIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137407 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other