BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON OPTEMP II CAUTERY

    MDR report key: 1648165 · Received March 31, 2010

    Report

    Report Number
    1045254-2010-00012
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 4, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HQP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. ALCON STATED TO MEDTRONIC THAT THE PRODUCT IN QUESTION WILL NOT BE RETURNED FOR ANALYSIS. WITHOUT A PRODUCT ANALYSIS, IT CANNOT BE DETERMINED IF THE CAUTERY MET PRODUCT SPECIFICATION. THE PATIENT'S CURRENT OR LONG TERM PROGNOSIS WAS NOT RELEASED TO MEDTRONIC. THE ONLY CONCLUSION IS THAT THE PATIENT RECEIVED A BURN TO THE TIP OF MIDDLE FINGER ON THE RIGHT HAND. (B) (6). THE AVAILABLE INFORMATION INDICATES THE EVENT DATE WAS ON OR BEFORE (B) (6) 2010. THE TWO EVENT DESCRIPTIONS PROVIDED WERE AS FOLLOWS: DURING DIATHERMY ON A WART ON A PATIENT'S FINGER, THE TIP OF THE OPTEMP CAUGHT FIRE AND PLASTIC DRIPPED ONTO THE PT'S FINGER CAUSING A BURN. REMOVE A SMALL LESION FROM A PT'S FINGER, THE PLASTIC FROM AROUND THE CAUTERY TIP MELTED AND FELL ONTO STANDARD SURGICAL GAUZE UNDER THE PATIENT'S FINGER AND CAUSED THE GAUZE TO CATCH FIRE AND BURN 30% OF THE TIP OF THE PATIENT'S FINGER." ALCON MANUFACTURING WAS QUESTIONED "WHAT PREPARATION AGENTS WERE USED?" AND THE REPLY WAS ONLY THAT "NO ALCOHOL PREPARATIONS WERE USED". IFU 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 PATIENT 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 PATIENT INJURY. A REVIEW OF THE AVAILABLE COMPLAINT HISTORY INDICATES THAT THERE ARE NO SIMILAR REPORTS FOR THIS PRODUCT FAMILY. NO ANOMALIES OR NON-CONFORMANCES WERE FOUND IN THE MANUFACTURING RECORDS FOR THIS LOT. (B) (4) PRODUCT "ALCON OPTEMP II HIGH TEMPERATURE STERILE DISPOSABLE CAUTERY". (B) (4)

    Description of Event or Problem · 1

    DURING A DIATHERMY ON A WART, THE PATIENT RECEIVED A BURN ON THE RIGHT MIDDLE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON OPTEMP II CAUTERY 86HQP HQP MEDTRONIC XOMED, INC. 8065004603 59894900

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability