BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANARUS VISICA TREATMENT SYSTEM

    MDR report key: 496940 · Received November 13, 2003

    Report

    Report Number
    3003515897-2003-00009
    Event Type
    Malfunction
    Date Received
    November 13, 2003
    Date of Event
    November 7, 2003
    Report Date
    November 11, 2003
    Manufacturer
    SANARUS MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE VISICA TREATMENT SYSTEM TO CRYOABLATE A FIBROADENOMA. DURING THE PROCEDURE, A 1 CM BAND OF FROST WAS OBSERVED ON THE PORTION OF THE PROBE THAT IS PROXIMAL TO THE SKIN. THE AREA OF FROST WAS NOT NEAR THE SKIN AND WAS LOCATED APPROXIMATELY 1 CM DISTAL TO THE PLASTIC HANDLE. SINCE THE FROST WAS NOT NEAR THE SKIN, THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANARUS VISICA TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS MEDICAL, INC. VP0500 V030901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other