BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 1853345 · Received September 29, 2010

    Report

    Report Number
    1717344-2010-00674
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 15, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SURGEON ATTEMPTED TO REMOVE A WART FROM A PT'S FACE, A SMALL BALL OF FIRE FORMED ON A DEVICE (MFR UNK), AND LIT THE STERILE CLOTH WHICH COVERED THE PT'S FACE ON FIRE, WHICH THEN BURNT THE INSIDE OF THE PT'S NOSE. A PIECE OF THE DEVICE FELL OFF AND SERIOUSLY BURNT THE SURGEON'S LEG. THE PT BURN WAS TREATED WITH CREAM. THE SURGEON IS STILL RECEIVING TREATMENT FOR THE BURN ON HER LEG. THE SITE REPORTED THIS INCIDENT WAS DUE TO USER ERROR DUE TO AN ACCUMULATION OF OXYGEN UNDER THE STERILE CLOTH PRIOR TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other