BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-TEMP CAUTERY

    MDR report key: 1729887 · Received June 16, 2010

    Report

    Report Number
    1045254-2010-00023
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HQP
    PMA / PMN Number
    K771189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT IN QUESTION WAS MFG WITH NO ANOMALIES AND WITHOUT NON-CONFORMANCES. ELECTRICAL AND FUNCTIONAL INSPECTION SHOWED THAT THE RESISTANCE AND VOLTAGE OF THE DEVICE WAS WITHIN SPEC. VISUAL INSPECTION UNDER A MICROSCOPE SHOWED NO DAMAGE OR DEFECT TO ANY PORTION OF THE DEVICE. THE PRODUCT ANALYSIS CONCLUDES THAT THE DEVICE WAS PERFORMING TO SPEC. ADDITIONAL INFO FROM THE FACILITY INDICATED OXYGEN WAS USED DURING THIS PROCEDURE, THE DEVICE WAS USED IN CLOSE PROXIMITY OF FLAMMABLE MATERIALS, AND WATER BASED PREPARATORY AGENTS WERE NOT USED AS DIRECTED. A LOCAL ANESTHETIC WAS USED, HOWEVER, THE TYPE AND / OR NAME WAS NOT DISCLOSED. THE INSTRUCTIONS FOR USE STATEMENTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING STATEMENTS; FIRE WARNING: HEAT GENERATED BY THE TIP CAN IGNITE FLAMMABLE MATERIALS. DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS SUCH AS FACIAL HAIR, PREPARATION AGENTS, ALCOHOL VAPORS, DRAPES, OR GOWNS. USE OF THE DEVICE IN AN OXYGEN ENRICHED ATMOSPHERE (E.G. ANESTHESIA) ABOVE 21% OXYGEN CONCENTRATION CAN CAUSE FUEL SOURCES TO IGNITE, RESULTING IN PT INJURY. PROPER SURGICAL TECHNIQUE, SUCH AS THE APPLICATION OF WATER-BASED LUBRICANT TO FACIAL HAIR NEAR THE SURGICAL SITE OF ELECTROCAUTERY USE, MUST BE FOLLOWED TO PREVENT POTENTIAL PT INJURY.

    Description of Event or Problem · 1

    DURING EYE SURGERY (CONJUNCTIVE COAGULATION IN THE RIGHT EYE), THE PT SUSTAINED SUPERFICIAL BURNS ON THE CHEEK AND THE NECK WHEN IT WAS DESCRIBED THAT "A FLAME WENT OVER THE FACE, THE DRAPES AND IN THE NASAL FOSSE". BOTH THE CHEEK AND NECK ARE GETTING BETTER. THE BURNS IN THE NASAL FOSSE REQUIRED PLASTIC CYLINDERS TO PREVENT ADHESIONS. THE PT STILL HAS NOT MADE A FULL RECOVERY IN THE OLFACTIVE AREA AND THE CORNEA IS STILL UNCERTAIN. IT HAS BEEN REPORTED THAT THE GENERAL STATE OF PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-TEMP CAUTERY HQP - UNIT, CAUTERY, THERMAL, BATTERY-POWERED HQP MEDTRONIC XOMED, INC. 4882000 65142000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention