BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 3171957 · Received May 29, 2013

    Report

    Report Number
    3171957
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 29, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LIGASURE IMPACT INSTRUMENT WOULDN'T CUT THE TISSUE DURING A CASE. A NEW IMPACT WAS OPEN AND USED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NEPHRECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236110 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION GEI COVIDIEN LP * 2409026X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR