BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 5161392 · Received October 20, 2015

    Report

    Report Number
    5161392
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    July 28, 2015
    Report Date
    September 21, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP WITH THE DR REGARDING LOCATION OF ELECTROSURGICAL PENCIL (BOVIE HANDLE WITH TIP) REVEALED THAT WHEN IT WAS NOT IN USE, THE ELECTROSURGICAL PENCIL WAS PLACED ON THE MAYO STAND. ONLY WHEN THE DR WAS USING THE ELECTROSURGICAL PENCIL WAS THERE CONTACT WITH THE PATIENT'S LIP. THE CONTACT WAS FOR RETRACTION OF THE LIP FOR CLEAR VISUALIZATION OF THE SURGICAL AREA. PER THE DR: THERE WERE FULL THICKNESS BURNS TO THE ORAL COMMISSURE INVOLVING THE CUTANEOUS SKIN MUCOSA AND SOME OF THE UNDERLYING MUSCULARIS. THE WOUNDS ARE CLEAN AND THERE ARE NO SIGNS OF INFECTION. WOUNDS MEASURE APPROXIMATELY 8MM X 8MM WHEN MOUTH IS OPEN. WHEN HER MOUTH IS CLOSED THEY (WOUNDS) ARE VERY DIFFICULT TO SEE. PATIENT SHOULD CONTINUE WITH THE CURRENT THERAPY OF KEEPING THE WOUNDS CLEAN AND MOIST. THEY WILL HEAL. WILL SEE PATIENT BACK IN 2 WEEKS. STRETCHING EXERCISES MIGHT NEED TO BE INITIATED OR NIGHTTIME SPLINTS TO MANAGE SCAR CONTRACTURE ONCE THE WOUNDS BEGIN TO CONTRACT AND TIGHTEN. PATIENT SELF-MANAGEMENT (PSM) IS BEING WORKED ON. QUALITY AND PATIENT SAFETY (QPS) WERE NOTIFIED. DURING A TONSILLECTOMY AND ADENOIDECTOMY, BURNING OF THE CORNERS OF THE MOUTH BILATERALLY WAS NOTED. AFTER THE CASE, IT WAS NOTED THAT THE BOVIE TIP THAT HAD BEEN CHANGED BEFORE THE BEGINNING OF THE CASE HAD NOT BEEN PUSHED IN ALL THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692386 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR