BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR TIP

    MDR report key: 15151 · Received April 30, 1994

    Report

    Report Number
    15151
    Event Type
    Other
    Date Received
    April 30, 1994
    Date of Event
    April 21, 1994
    Report Date
    April 29, 1994
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORAL SURGEON WAS USING THE BIPOLAR FORCEPS AS AN ACCESSORY OF AN ELECTROSURGICAL UNIT FOR A MICROSCOPIC PROCEDURE INTRAORALLY. SURGERY WAS STOPPED IMMEDIATELY WHEN THE SURGICAL TECH NOTICED THE FORCEPS WERE EXCEEDINGLY HOT. OBSERVING THE TIP OF THE FORCEPS UNDER THE MICROSCOPE, THE SURGEON MAY HAVE INADVERTENTLY PINCHED A PORTION OF THE LOWER LEFT LIP INTO THE FORCEPS AT THE BENT PORTION OF THE SHAFT. THUS CREATING A SECOND DEGREE BURN. TO IMPROVE THE DESIGN OF THIS PORTION OF THE BIPOLAR UNIT, IT SHOULD BE INSULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR TIP BIPOLAR TIP GEI CODMAN AND SHURTLEFF, INC. MF380

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other