BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 37085 · Received September 10, 1996

    Report

    Report Number
    2916288-1996-00003
    Event Type
    Injury
    Date Received
    September 10, 1996
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING AN ORAL SURGERY PROCEDURE, THE PT SUSTAINED A BURN TO THE MIDPORTION OF THE UPPER LIP. A CO DISPOSABLE 6" BLADE ELECTRODE WAS INSERTED INTO ANOTHER CO'S HANDSWITCHING PENCIL CONNECTED TO ANOTHER CO'S SOLID STATE ELECTROCAUTERY UNIT USED FOR THE PROCEDURE. BIOMEDICAL ENGINEERING CHECKED THE EQUIPMENT AND COULD NOT IDENTIFY A PROBLEM OR DUPLICATE THE SITUATION WHERE A BURN COULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN DISPOSABLE 6" BLADE ELECTRODE GEI OLSEN ELECTROSURGICAL, INC. 970 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other