BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 495332 · Received November 10, 2003

    Report

    Report Number
    3003515897-2003-00005
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    August 2, 2002
    Report Date
    November 7, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED CRYOABLATION TREATMENT OF A LARGE FIBROADENOMA WITH THE VISICA TREATMENT SYSTEM IN 2002. THE TEMPERATURE SENSOR ON THE CONSOLE DISPLAYED ABERRANT READINGS; HOWEVER THE DEVICE PERFORMED AS INTENDED AND THE TREATMENT WAS COMPLETED ACCORDING TO INSTRUCTIONS FOR USE.

    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 Required Intervention