BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCOPE

    MDR report key: 835704 · Received March 13, 2007

    Report

    Report Number
    835704
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    January 4, 2007
    Report Date
    March 13, 2007
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE THE FOOT PEDAL FOR THE MICROSCOPE AND IT WOULD NOT OPERATE. A BACK UP MICROSCOPE WAS USED. BIOMED ASSESSMENT: REPAIRED BROKEN WIRE IN CABLE AND RETURNED UNIT TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCOPE MICROSCOPE, SURGICAL EPT LEICA MICROSYSTEMS, INC. M841EBS *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR