BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4538867 · Received January 15, 2015

    Report

    Report Number
    4538867
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 15, 2015
    Manufacturer
    LEICA MICROSYSTEMS, INC
    Product Code
    FSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER PATIENT WAS PREPARED AND DRAPED, MICROSCOPE WAS BROUGHT INTO POSITION. PHYSICIAN NOTED FOOT PEDAL WAS NOT FUNCTIONING. STAFF CHECKED CONNECTION BETWEEN FOOT PEDAL AND MICROSCOPE, WHICH WAS PATENT; HOWEVER, MICROSCOPE FOOT PEDAL DID NOT WORK. REPLACED WITH ANOTHER MICROSCOPE, WHICH ALSO DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36793 * MICROSCOPE, SURGICAL FSO LEICA MICROSYSTEMS, INC * *
    36794 * MICROSCOPE, SURGICAL FSO LEICA MICROSYSTEMS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR