BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO EYE SCOPE

    MDR report key: 32038 · Received February 22, 1996

    Report

    Report Number
    32038
    Event Type
    Malfunction
    Date Received
    February 22, 1996
    Date of Event
    August 11, 1995
    Report Date
    November 30, 1995
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING (RIGHT EYE) CATARACT PHACOEMULSIFICATION WITH LENS IMPLANTATION AND WHILE LOWERING THE MICROSCOPE INTO POSITION BY THE SURGEON, THE SCOPE CAME LOOSE AND STARTED TO FALL ONTO PT. THE CIRCULATING OR NURSE GRABBED UNDER AND HELD THE SCOPE. PHYSICIAN AND NURSE PUT SCOPE BACK INTO POSITION AND REATTACHED IT. CO TECH FOUND THAT THE SECURITY SCREW COULD HAVE WORKED ITS WAY OUT DUE TO BREAKDOWN IN LUBRICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO EYE SCOPE MICRO EYE SCOPE EPT CARL ZEISS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR