BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC ELECTROSURGICAL PENCIL

    MDR report key: 8960649 · Received September 4, 2019

    Report

    Report Number
    8960649
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 16, 2019
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNINTENTIONAL ACTIVATION OF A DEROYAL EXTENDEVAC ELECTROSURGICAL PENCIL REF: 88-00072. FOUR INCIDENTS REPORTED REGARDING THIS PRODUCT MALFUNCTION, TWO HAVE RESULTED IN INJURY TO PATIENTS (BURNS TO THIGH AND BREAST) AND TWO NEAR MISS EVENTS. FIRST INCIDENT: IT WAS NOTICED THAT THE ELECTROSURGICAL PENCIL WAS ACTIVATING WHILE NOT IN USE AND CAUSED A BURN APPROXIMATELY 2.5 CM TO THE PATIENT'S LEFT ANTERIOR THIGH. THE BURN WAS EXCISED, THE INCISION WAS CLOSED AND DRESSED WITH STERI-STRIPS AND A MEPILEX DRESSING. SECOND INCIDENT: AT THE BEGINNING OF THE CASE, THE SURGEON STARTED USING THE BOVIE (DEROYAL EXTENDEDVAC ELECTROSURGICAL PENCIL (REF 88-000722, LOT 50071481) AND AS HE FINISHED USING IT, THE BOVIE PENCIL DID NOT TURN OFF. THE DEVICE WAS UNPLUGGED FROM THE MACHINE AND RE-PLUGGED AND STILL BUZZED AS IF IT WAS BURNING TISSUE, BUT IN FACT IT WAS TURNED OFF AT THE HAND PIECE. NO PATIENT HARM. THIRD INCIDENT: EVENT REPORTED AT ANOTHER FACILITY: THE CAUTERY PENCIL REMAINED ACTIVE WITHOUT FINGER CONTROL ACTIVATING THE PENCIL. IT WAS SET ON THE PATIENT AND UNINTENTIONALLY CAUSED A BURN TO THE PATIENT'S BREAST. THE CAUTERY DEFECT WAS REPLICATED IMMEDIATELY AFTER THE EVENT IN THE O.R BY THE SURGEON. IT WAS TAKEN OUT OF SERVICE AND A NEW CAUTERY PENCIL WAS OBTAINED. A PRODUCT CONCERN WAS INITIATED. EXTENDVAC ELECTROSURGICAL PENCIL REF#88-000722, LOT#49031182. FOURTH INCIDENT: THE COAG BUTTON ON THE CAUTERY PENCIL REMAINED ACTIVATED EVEN THOUGH THE SURGEON WASN'T PRESSING THE BUTTON. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756618 EXTENDEVAC ELECTROSURGICAL PENCIL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI DEROYAL INDUSTRIES, INC. 49031182,50071481

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA