BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMERA 700

    MDR report key: 3847159 · Received May 29, 2014

    Report

    Report Number
    3847159
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 7, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    HRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE RESIGHT, PART OF THE MICROSCOPE, FELL OFF (THE SCREW WHICH HOLDS THE RESIGHT CAME LOOSE) AND LANDED ON THE RIGHT NECK OF THE PATIENT - CONTAMINATING THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317282 LUMERA 700 MICROSCOPE, SURGICAL HRM CARL ZEISS MEDITEC, INC. LUMERA700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR