BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 84316 · Received April 4, 1997

    Report

    Report Number
    2916288-1997-00003
    Event Type
    Injury
    Date Received
    April 4, 1997
    Report Date
    April 4, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS SLIGHTLY BURNED ON THE SKIN EDGES OF INCISION. LEAKAGE OF CURRENT ON THE FORCEPS BODY OCCURRED DUE TO CUT IN INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN MONOPOLAR FORCEPS GEI OLSEN ELECTROSURGICAL, INC. 120 015565

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other