BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AMERICA INC

    MDR report key: 153854 · Received February 26, 1998

    Report

    Report Number
    153854
    Event Type
    Malfunction
    Date Received
    February 26, 1998
    Date of Event
    January 13, 1998
    Report Date
    January 27, 1998
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    72 Y/O MALE ADMITTED FOR CYSTOSCOPY. WHEN TURNING ON THE BOVIE MACHINE, THE CORD SPARKED AND POPPED. THE UNIT WAS IMMEDIATELY TURNED OFF, AND DISCONNECTED. THE CORD BROKE INTO TWO WHEN IT WAS REMOVED FROM THE BOVIE MACHINE. NO ADVERSE OUTCOME WAS NOTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AMERICA INC BOVIE CAUTERY CORD DSA OLYMPUS AMERICA, INC. AO336.1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other