BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1972502 · Received January 21, 2011

    Report

    Report Number
    1717344-2011-00050
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    COVIDIEN LP (VALLELAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE CAUSED A BURN ON THE PT'S INNER LABIA AND VAGINAL WALL ON BOTH THE RIGHT AND LEFT SIDES DURING A HYSTERECTOMY. THE DEGREE OF BURN AND PT STATUS IS UNK. ADDITIONAL QUESTIONS HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLELAB) 184921L

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR