BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOVIE

    MDR report key: 436499 · Received January 8, 2003

    Report

    Report Number
    436499
    Event Type
    Other
    Date Received
    January 8, 2003
    Date of Event
    May 16, 2002
    Report Date
    May 21, 2002
    Manufacturer
    DAVOL, INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TITLE: DAVOL [ BOVIE ] ESU. PERFORMING A TRACHEOSTOMY [WHILE THE PATIENT WAS ON A VENTILATOR]. THE SKIN AT THE BASE OF NECK ANESTHETIZED WITH 1% LIDOCAINE WITH EPINEPHRINE. A TRANSVERSE INCISION WAS MADE. THE SUBCUTANEOUS TISSUE WAS DIVIDED WITH ELECTROCAUTERY [USING THE BOVIE ELECTROSURGICAL UNIT (ESU)]. UPON MAKING THE INCISION, THE ENDOTRACHEAL TUBE WAS ENCOUNTERED. THE TUBE ITSELF ACTUALLY CAUGHT FIRE WITHIN THE TRACHEA. IT WAS EXTINGUISHED WITH A TOWEL. A WET SPONGE WAS APPLIED TO SITE. THE AREA AROUND THE TRACH SITE WAS CLEANSED. REDNESS WAS NOTED AROUND THE INCISION SITE [WITHOUT ANY SIGNIFICANT DEGREE BURN NOTED]. SILVADENE OINTMENT WAS ORDERED BY THE PHYSICIAN [AND APPLIED TO THE SITE. THE NEW TRACH TUBE WAS PLACED WITHOUT COMPLICATIONS TO THE PATIENT. IT IS NOT KNOWN HOW LONG AFTER THIS EVENT THE NEW TUBE WAS INSERTED. IT IS NOT KNOWN IF ANY OTHER SURGICAL MATERIALS WERE BURNED. THE PHYSICIAN WAS USING OXYGEN WHILE PERFORMING ELECTROCAUTERY. THE LABELING INSTRUCTIONS OF THE BOVIE ESU CAUTION USE OF THIS DEVICE WHEN OXYGEN IS IN USE. ACCORDING TO THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT'S APPRAISAL, USER ERROR WAS INVOLVED IN THIS EVENT BECAUSE OF THE ESU BEING USED IN CONJUNCTION WITH OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE ELECTROSURGICAL UNIT [ESU] GEI DAVOL, INC. 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other