BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE

    MDR report key: 10789314 · Received November 4, 2020

    Report

    Report Number
    1717344-2020-01359
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    August 13, 2020
    Report Date
    November 4, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521186033
    PMA / PMN Number
    K152286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: REDUCED MORBIDITY BY USING LIGASURE COMPARED TO CONVENTIONAL INGUINOFEMORAL LYMPHADENECTOMY IN VULVAR CANCER PATIENTS: A RANDOMIZED CONTROLLED TRIAL. SOURCE: SURGICAL ONCOLOGY VOLUME 35, DECEMBER 2020, PAGES 149-15 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY, BETWEEN OCTOBER 2017 AND OCTOBER 2018, 20 PATIENTS WITH 40 GROINS REQUIRING BILATERAL INGUINOFEMORAL LYMPHADENECTOMY (IFL) WERE INCLUDED IN THIS STUDY. TEN PATIENTS WERE ALLOCATED TO IFL WITH LIGASURE IN THE RIGHT GROIN AND TEN PATIENTS WERE ALLOCATED TO LIGASURE IN THE LEFT GROIN. POSTOPERATIVE SHORT-TERM COMPLICATIONS REQUIRING TREATMENT OCCURRED IN 6/20 GROINS TREATED WITH LIGASURE: 1 WOUND INFECTION; 4 WOUND INFECTION AND LYMPHOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253971 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF1212A 10884521186033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other