BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1980795 · Received January 26, 2011

    Report

    Report Number
    1980795
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 26, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    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 WAS USED TO RESECT THE BLADDER. IT WOULD CLOSE AROUND THE TISSUE, BUT NOT SEAL; THE DEVICE WAS WORKING BUT THEN STOPPED WORKING AND AN ERROR MESSAGE WAS DISPLAYED. THE SURGEON SUGGESTED THAT THIS MALFUNCTION MAY HAVE RESULTED IN EXCESSIVE BLEEDING FROM THE TISSUE. PT REQUIRED BLOOD PRODUCT RESUSCITATION BUT SUSTAINED NO PERMANENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 193608L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR