BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 5769293 · Received July 5, 2016

    Report

    Report Number
    3008087395-2016-00004
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 5, 2016
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    PMA / PMN Number
    K062896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PREPARED FOR PROCEDURE. PROBE TEST PASSED AND SIZE OF LESION WAS ENTERED INTO THE SYSTEM. THE MONITOR BEGAN TO FLICKER WITH THE GREEN LIGHT REMAINING ON. THE CASE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424567 VISICA 2 TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS TECHNOLOGIES INC. VS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention