BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 858537 · Received May 25, 2007

    Report

    Report Number
    1717344-2007-00146
    Event Type
    Injury
    Date Received
    May 25, 2007
    Date of Event
    January 17, 2007
    Report Date
    April 25, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ALSO A RESPONSE TO A REQUEST FOR INFO FROM FDA IN THE LETTER DATED 01/30/2007 BUT POST-MARKED 4/23/2007 AND RECEIVED 04/25/2007. QUESTIONS FROM THE REQUEST FOR INFO LETTER: WHY BOTH FOOT PEDAL AND HAND ACTIVATED ELECTRODE WERE BEING USED AT THE SAME TIME? DID THEY NEED BOTH FOR A REASON? DOES YOUR GENERATOR HAVE A SAFETY FEATURE TO PREVENT UNINTENTIONAL ACTIVATION OF THE ELECTRODE? THE FX GENERATOR IS DESIGNED TO ALLOW THE CUSTOMER TO USE EITHER HAND OR FOOT SWITCHING WHEN USING A HANDSWITCHING PENCIL. THE USERS GUIDE FOR THE FORCEFX ON PAGE 5-6 IN THE SECTION HEADING "ACTIVATING THE SURGICAL INSTRUMENT" STATES "TO ACTIVATE A HANDSWITCHING INSTRUMENT, USE THE CONTROLS ON THE INSTRUMENT OR ON THE APPROPRIATE FOOTSWITCH. TO ACTIVATE A FOOTSWITCHING INSTRUMENT, YOU MUST USE A FOOTSWITCH." THE FORCEFX GENERATOR HAS BEEN IN USE SINCE 1995 AND THERE IS NO HISTORY OF USER ERROR REGARDING THIS DESIGN. THE INSTRUCTIONS FOR USE (IFU) FOR THE "STERILE, SINGLE USE HANDSWITCHING PENCIL" UNDER "WARNINGS" STATES "ELECTROSURGICAL ACCESSORIES THAT ARE ACTIVATED OR HOT FROM USE CAN CAUSE A FIRE. WHEN NOT USING ACTIVE ACCESSORIES, PLACE THEM IN A HOLSTER OR IN A CLEAN DRY, NONCONDUCTIVE, AND HIGHLY VISIBLE AREA NOT IN CONTACT WITH THE PT. INADVERTENT CONTACT WITH THE PT MAY RESULT IN BURNS." THE IFU ALSO SHOWS PICTURES AND INSTRUCTIONS ON HOW THE HOLSTER CAN BE ATTACHED TO THE DRAPES. WHAT DO YOU THINK THE USERS NEED IN TERMS OF SAFETY TIPS? IN ADDITION TO THE PRODUCT LABELING, VALLEYLAB DISCUSSES USE OF THE HOLSTERS IN NUMEROUS "HOTLINE" COMMUNICATIONS ON OUR WEBSITE. IF THE PENCIL IS PLACED IN A HOLSTER INSTEAD OF BEING LAID ON THE PT, ACCIDENTAL ACTIVATION CAN CAUSE NO HARM.

    Description of Event or Problem · 1

    THIS WAS A MEDWATCH FORM RECEIVED FROM THE FDA WHICH STATED THAT THE PT WAS UNDERGOING A BILATERAL REDUCTION MAMMOPLASTY AND SUSTAINED A 3MM BY 3MM FULL-THICKNESS BURN TO RIGHT UPPER MEDIAL CHEST. THE BURN OCCURRED WHEN CAUTERY PENCIL WAS PLACED ON THE PT'S CHEST AND WAS ACTIVATED IN CUT MODE BY A STAFF MEMBER WHO ACCIDENTALLY STEPPED ON THE FOOT PEDAL. BURN WAS EXCISED AND AREA SUTURED BY SURGEON WHILE PT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI VALLEYLAB * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention