BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISICA 2 TREATMENT SYSTEM

    MDR report key: 7176877 · Received January 9, 2018

    Report

    Report Number
    3008087395-2017-00006
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    November 28, 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

    THE PHYSICIAN REPORTED THAT THE PATIENT HAD MINOR FROSTBITE AT THE INCISION SITE. THE SYSTEM WAS TURNED ON PREMATURELY CAUSING THE ICE TO FORM BEFORE THE PROBE WAS COMPLETELY POSITIONED. AT THE TIME, THE PATIENT DID NOT HAVE ANYTHING VISIBLY WRONG WITH HER. IT WAS LATE DISCOVERED AT A FOLLOW UP APPOINTMENT THAT THE PATIENT DID INDEED HAVE FROSTBITE AT THE SITE OF THE INCISION; BUT IT HAS BEEN TAKEN CARE OF AND THERE ARE NO LONG TERM SIDE EFFECTS TO REPORT ACCORDING THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20542 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