BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 7176878 · Received January 9, 2018

    Report

    Report Number
    3008087395-2017-00005
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 9, 2018
    Manufacturer
    SANARUS TECHNOLOGIES INC.
    Product Code
    GEH
    UDI-DI
    00868390000228
    PMA / PMN Number
    K062896
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE FIRST 30 SECONDS OF THE FIRST FREEZE THE PHYSCIAN NOTICED THE PROBE SHAFT WAS FREEZING UP TOWARDS THE HANDLE. HE IMMEDIATELY STOPPED THE PROCEDURE AND REMOVED THE PROBE. ANOTHER PROBE WAS USED TO COMPLETE THE PROCEDURE. INITIAL REPORT FROM THE SITE STATED THERE WAS NO INJURY TO THE PATIENT. DURING A FOLLOW UP VISIT IT WAS STATED THAT THE PATIENT SUFFERED A FIRST DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20543 VISICA 2 TREATMENT SYSTEM CRYOABLATION SYSTEM, PRODUCT CODE: GEH GEH SANARUS TECHNOLOGIES INC. V2 ICE PROBE 00868390000228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention