BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PICO S-100 FLOOR STAND

    MDR report key: 609656 · Received July 9, 2004

    Report

    Report Number
    2431026-2004-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2004
    Date of Event
    February 3, 2004
    Report Date
    July 6, 2004
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING MAINTENANCE, ONE OF FOUR CASTERS CAME LOOSE FROM THE SURGICAL MICROSCOPE STAND BASE. SALES REPRESENTATIVE EXPERIENCED A MILD MUSCLE STARIN INATTEMPTING TO RIGHT STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PICO S-100 FLOOR STAND SURGICAL MICROSCOPE EPT CARL ZEISS, INC. MODEL: 108-324 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death