BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 495330 · Received November 10, 2003

    Report

    Report Number
    3003515897-2003-00006
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    February 9, 2003
    Report Date
    November 7, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURNG A SALES DEMONSTRATION, A COMPANY REPRESENTATIVE NOTED THAT THE VISICA TREATMENT SYSTEM DEMONSTRATED FROSTING UP THE SHAFT OF THE DEVICE, WHERE IT SHOULD BE INSULATED FROM COLD. THE DEVICE WAS NOT USED IN A PATIENT, AND WAS USED DURING A DEMONSTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other