BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 5740114 · Received June 21, 2016

    Report

    Report Number
    3008087395-2016-00003
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    May 26, 2016
    Report Date
    June 21, 2016
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    PMA / PMN Number
    K062896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE SECOND FREEZE CYCLE WITH 2 OF THE 4 MINUTES LEFT TWO SYSTEM FAULT CODES WERE POSTED ON THE SYSTEM SCREEN. THE FAULT CODES 4 AND 13 WERE DISPLAYED. PROCEDURE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394620 VISICA 2 TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS TECHNOLOGIES INC. VS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention