BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 131107 · Received November 6, 1997

    Report

    Report Number
    2916288-1997-00007
    Event Type
    Injury
    Date Received
    November 6, 1997
    Report Date
    November 6, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING AN ORAL SURGERY, THE PT SUFFERED A BURN TO THE MOUTH. AN OLSEN, HAND-ACTIVATED, DISPOSABLE SWITCHPEN WAS USED WITH A MEGADYNE BLADE ELECTRODE. BIOMEDICAL ENGINEERING AND THE OPERATIVE NURSE STATE THAT THE FIT AND OPERATION OF THE INSTRUMENT IS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN DISPOSABLE, HAND-ACTIVATED SWITCHPEN GEI OLSEN ELECTROSURGICAL, INC. 755VL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other