BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 4251463 · Received November 7, 2014

    Report

    Report Number
    MW5039031
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 7, 2014
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT THE ONSET OF A TONSILLECTOMY, THE ELECTROCAUTERY PENCIL TIP SPARKED. FLAMED AND SMOKED. THE SURGEON IMMEDIATELY RELEASED THE HAND CONTROL BUTTON AND REMOVED THE DEVICE FROM THE MOUTH. NO INJURY OR BURN OCCURRED TO ANY TISSUE EXCEPT TO THE TONSIL BEING REMOVED. THE PATIENT SUFFERED NO INJURY. THE ELECTROCAUTERY UNIT WILL BE RETURNED TO COVIDIEN AT THEIR REQUEST, FOR INSPECTION/REPAIR. IT IS A FORCE FX CZD. THE EDGE BUTTON SWITCH PENCIL BLADE AND EDGE INSULATED BLADE ELECTRODE WERE ALSO SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718514 COVIDIEN PENAL GEI 42240151X
    718571 COVIDIEN EDGE INSULATED BLADE ELECTRODE GEI COVIDIEN MANSFIELD, MA 2.75 41710261X
    718572 COVIDIEN ELECTROCAUTERY UNIT GEI

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention