BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 5215642 · Received November 10, 2015

    Report

    Report Number
    3008087395-2015-00123
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    August 31, 2015
    Report Date
    October 6, 2015
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    PMA / PMN Number
    K062896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PROBE WAS TESTED TWICE BY THE CLINICAL TECHNICIAN. SHE INSPECTED THE PROBE ON BOTH TESTS FOR BUBBLES AND/OR FROST ON THE PROBE SHAFT WITH NO EVIDENCE OF EITHER DURING THE TESTS. THE PHYSICIAN INSERTED THE PROBE INTO THE BREAST TO TREAT THE FIBROADENOMA. SHORTLY AFTER PROCEDURE STARTED FROST STARTED TO FORM ON THE PROBE. PHYSICIAN IRRIGATED THE SITE WITH SALINE SOLUTION CONSTANTLY DURING THE REMAINDER OF THE PROCEDURE. POST PROCEDURE, THE PATIENT'S SKIN AT THE PROBE INSERTION SITE WAS IRRITATED AND RED WHICH THE PHYSICIAN EVALUATED AS A FIRST DEGREE BURN ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744242 VISICA 2 TREATMENT SYSTEM VISICA 2 ICE PROBE GEH SANARUS TECHNOLOGIES INC. VP0600 V2140901

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention