BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 518381 · Received January 30, 2004

    Report

    Report Number
    9610773-2004-00011
    Event Type
    Malfunction
    Date Received
    January 30, 2004
    Report Date
    January 5, 2004
    Manufacturer
    OLYMPUS WINTER & LBE GMBH
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THE DEVICE SPARKED WHILE BEING SET-UP FOR A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH USE OF ANOTHER DEVICE. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LOOP ELECTRODE JOS OLYMPUS WINTER & LBE GMBH A22201C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN