BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 2851398 · Received October 30, 2012

    Report

    Report Number
    1717344-2012-01129
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 10, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MOST LIKELY, AN LF4200 DEVICE WAS USED DURING THIS SURGERY. THE IFU FOR THIS DEVICE STATES THAT DURING A SEAL CYCLE, ENERGY IS APPLIED TO THE AREA BETWEEN THE INSTRUMENT JAWS. THIS ENERGY MAY CAUSE WATER TO BE CONVERTED INTO STEAM. THE THERMAL ENERGY OF STEAM MAY CAUSE UNINTENDED INJURY IN CLOSE PROXIMITY TO THE JAWS. CARE SHOULD BE TAKEN IN SURGICAL PROCEDURES OCCURRING IN CONFINED SPACES IN ANTICIPATION OF THIS POSSIBILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE PATIENT WAS RELEASED FROM THE HOSPITAL FOR A VAGINAL HYSTERECTOMY, SHE NOTICED A STEAM BURN TO HER LABIA. THE BURN WAS DESCRIBED AS BEING ABOUT THE SIZE OF A HALF-DOLLAR WITH WHITE ESCHAR. THE BURN WAS TREATED WITH SILVADENE OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LIGASURE INSTRUMENT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK