BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN MEDTRONIC LIGASURE

    MDR report key: 10566189 · Received September 21, 2020

    Report

    Report Number
    MW5096773
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 17, 2020
    Manufacturer
    MEDTRONIC/COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGASURE DEVICE X 2 WITH INCOMPLETE SEAL CYCLE ERROR NOTIFICATIONS ON 2 DIFFERENT LIGASURE 5 MM 37 CM REF LF 1837. INSTRUMENT REPLACED AND PROCEDURE CONTINUED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029200 COVIDIEN MEDTRONIC LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC/COVIDIEN LF1837 01870014
    1029201 COVIDIEN MEDTRONIC LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC/COVIDIEN LF1837 10500262

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR