BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 7235626 · Received February 2, 2018

    Report

    Report Number
    3006451981-2018-00076
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 22, 2017
    Report Date
    February 1, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AT FIRST THE DEVICE WORKED WELL AS USUAL. BUT WHILE PERFORMING THE PROCEDURE, IT WAS NOTICED THAT THE COAGULATION FUNCTION OF THE DEVICE DECREASED CONSPICUOUSLY WITHIN JUST 5 MINUTES OF USE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78960 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S6CH713

    Patients

    Seq Age Sex Outcome Treatment
    1