BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FORCEPS 8-1/4"

    MDR report key: 17859 · Received November 18, 1994

    Report

    Report Number
    MW1004077
    Event Type
    Other
    Date Received
    November 18, 1994
    Date of Event
    November 4, 1994
    Report Date
    November 8, 1994
    Manufacturer
    OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS SPARKING FROM AN INSULATION DEFECT OF THE BAYONET FORCEPS. MUCOSAL BURNS OF RIGHT BUCCAL SURFACE AND LIP. THE SKIN WAS NOT INJURED. IT SHOULD HEAL WITHOUT SIGNIFICANT SCARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS 8-1/4" HAND CONTROLLED MONOPOLAR FORCEPS GEI OLSEN ELECTRO-SURGICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Other