BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 4999217 · Received August 11, 2015

    Report

    Report Number
    3008087395-2015-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    PMA / PMN Number
    K062896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT PROBE TEST WAS COMPLETED SUCCESSFULLY BY NURSE. THE 2.1CM FA LOCATED IN THE UPPER INNER QUADRANT AT 2 O'CLOCK POSITION. PERI-AREA INCISION AND INSERTED PROBE ON RIGHT LATERAL SIDE. POSITIONED PROBE WITH NO PROBLEM. DUE TO THE LOCATION OF THE LESION THE PROBE WAS TOUCHING THE NIPPLE AND SKIN SURFACE (6 CM). COMPLETED 1-2 MINUTES OF THE FIRST FREEZE AND PT COMPLAINED OF STINGING SENSATION. INSPECTED THE INSERTION SITE AND DISCOVERED THAT THE SHAFT OF THE PROBE HAD FROST ON IT. CHECKED THAT THE PT WAS COMFORTABLE AND SUBSEQUENTLY RE-POSITIONED PROBE TO ENSURE THAT IT WAS NOT TOUCHING THE SKIN SURFACE. COMPLETED THE PROCEDURE. AT THE END OF THE PROCEDURE PT WAS TREATED FOR FROST BITE TO SKIN THAT CAME IN CONTACT WITH THE PROBE SHAFT. TREATED PT BY EXCISING DAMAGED TISSUE RESULTING IN 4 MM X 6 CM INCISION. FOLLOWED UP WITH DAILY VISITS POST-TREATMENT FOR 6 DAYS AND CONTINUE TO MONITOR PT ON A WEEKLY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524877 VISICA 2 TREATMENT SYSTEM VISICA 2 ICE PROBE GEH SANARUS TECHNOLOGIES INC. VP0600 V2140901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention