BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESU FORCE 2-2PCH

    MDR report key: 2232572 · Received August 23, 2011

    Report

    Report Number
    1717344-2011-00744
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 23, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE UNIT IS RECEIVED OR 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 DURING A PACEMAKER INSERTION, A FLAME APPEARED NEAR THE PATIENT'S FACE WHILE OXYGEN WAS IN USE. THE PATIENT WAS BURNED ON THE CHEST, AROUND THE EAR AND ON THE TOP OF THE HEAD. THE BURNS WERE DESCRIBED AS BEING SECOND OR THIRD DEGREE BURNS. THE PATIENT IS CURRENTLY RECUPERATING IN THE ICU AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESU FORCE 2-2PCH ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization