BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARITRONICS

    MDR report key: 146408 · Received January 30, 1998

    Report

    Report Number
    146408
    Event Type
    Injury
    Date Received
    January 30, 1998
    Date of Event
    December 3, 1997
    Report Date
    December 19, 1997
    Manufacturer
    VARITRONICS
    Product Code
    HMT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN EYELID OPERATION: THE ELECTROSURGICAL OUTPUT SETTING WAS INCREASED FROM A 10 WATT SETTING TO 15 AND THEN TO 20 WATTS IN ORDER TO OBTAIN A STRONGER SPARK TO EASE THE CUTTING ACTION. WHEN THE PENCIL WAS ACTIVATED ON THE 20 WATT SETTING, A FLASH WAS EMITTED FROM THE TIP. THE CARDBOARD "NEVYAS" RETRACTOR IGNITED AND SPREAD TO THE PLASTIC DRAPE. THE FIRE WAS IMMEDIATELY EXTINGUISHED BY THE SURGEON. OXYGEN WAS TURNED OFF BY THE ANESTHESIOLOGIST. BURNED AREAS ON THE PT'S FACE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARITRONICS DRAPE RETRACTOR HMT VARITRONICS NEVYAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R