BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED

    MDR report key: 837984 · Received April 12, 2007

    Report

    Report Number
    1720159-2007-00016
    Event Type
    Other
    Date Received
    April 12, 2007
    Date of Event
    December 21, 2006
    Report Date
    March 23, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL DEVICES CALLED OUT IN THIS REPORT ARE UNAVAILABLE FOR EVALUATION DUE TO A COURT ORDERED SEQUESTER/QUARANTINE. EXCALIBUR PLUS PC SERVICE MANUAL. "SECTION 1.1.2 CAUTIONS FOR PATIENT PREPARATION". "ELECTROSURGERY SHOULD NEVER BE PERFORMED IN THE PRESENCE OF FLAMMABLE ANESTHETICS, FLAMMABLE PREP SOLUTIONS OR DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE (N2O), OR IN OXYGEN-ENRICHED ENVIRONMENTS. THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIALS IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN. PRECAUTIONS MUST BE TAKEN TO RESTRICT FLAMMABLE MATERIALS AND SUBSTANCES FROM THE ELECTROSURGICAL SITE, WHETHER THEY ARE PRESENT IN THE FORM OF AN ANESTHETIC, LIFE SUPPORT, SKIN PREPARATION AGENT, OR ARE PRODUCED BY NATURAL PROCESSES WITHIN BODY CAVITIES, OR ORIGINATE IN SURGICAL DRAPES, TRACHEAL TUBES, OR OTHER MATERIALS. THERE IS A RISK OF POOLING OF FLAMMABLE SOLUTIONS IN BODY DEPRESSIONS SUCH AS THE UMBILICUS AND IN BODY CAVITIES, SUCH AS THE VAGINA. ANY EXCESS FLUID POOLED IN THESE AREAS SHOULD BE REMOVED BEFORE THE EQUIPMENT IS USED. DUE TO THE DANGER OF IGNITION OF ENDOGENOUS GASES, THE BOWEL SHOULD BE PURGED AND FILLED WITH NONFLAMMABLE GAS PRIOR TO ABDOMINAL SURGERY. TO AVOID THE RISK OF TRACHEAL FIRES, NEVER USE ELECTROSURGERY TO ENTER THE TRACHEA DURING TRACHEOTOMY PROCEDURES."

    Description of Event or Problem · 1

    THE USER FACILITY STATED THIS EVENT TOOK PLACE APPROXIMATELY 3 MONTHS AGO DURING A TRACHEOTOMY PROCEDURE, UNDER GENERAL ANESTHESIA. ACCORDING TO INITIAL REPORTER, A FACIAL FIRE OCCURRED RESULTING IN 2ND/3RD DEGREE BURNS. IT WAS REPORTED THAT CONMED'S P/N 402-2204 AND 130309 WERE USED. THE PENCIL, HOWEVER, HAD BEEN MODIFIED BY REMOVING THE BLADE ELECTRODE AND INSERTING A MEGADYNE SILICON ELECTRODE. ACCORDING TO INITIAL REPORTER, THE MEGADYNE ELECTRODE HAD BEEN MODIFIED/BENT (ALMOST 90 DEGREES) BY THE SURGEON. THE PATIENT EVENTUALLY DIED, BUT ACCORDING TO THE O.R. DIRECTOR, THE DEATH WAS NOT A DIRECT RESULT OF THE FACIAL BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED EXCALIBUR PLUS PC GEI CONMED ELECTROSURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 130309: STANDARD PENCIL, PUSH BUTTON, BLADE| ADULT DISPERSIVE (FOR PATIENTS >80LBS.)| ELECTRODE| 402-2204: MACROLYTE DUAL DISPERSIVE ELECTRODE,