BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 264632 · Received February 18, 2000

    Report

    Report Number
    2916288-2000-00001
    Event Type
    Injury
    Date Received
    February 18, 2000
    Date of Event
    January 19, 2000
    Report Date
    February 17, 2000
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING TONSILLECTOMY SURGERY, PT WAS BURNED AT THE AREA SLIGHTLY ABOVE THE RIGHT CORNER OF THE MOUTH. THE BURN AREA EXCISED WAS APPROXIMATELY 4MM WIDE AND 1.5MM DEEP. THE HOSP EXAMINED THE FORCEP AND NOTED A 1/16 INCH DIAMETER VOID IN THE FORCEP INSULATION APPROXIMATELY 3 1/8 INCH FROM THE TIPS ON THE LEFT LEG OF THE FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN ELECTROSURGICAL MONOPOLAR FORCEP GEN OLSEN ELECTROSURGICAL, INC. 413-D 020248

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R