BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-CE CRYOABLATION SYSTEM

    MDR report key: 3130264 · Received May 22, 2013

    Report

    Report Number
    3004462490-2013-00013
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN PREPARATION FOR A CRYOABLATION PROCEDURE WITH THE VISUAL ICE SYSTEM, WHILE THE PATIENT WAS UNDER ANESTHESIA, THE USER RECEIVED AN "IN COMPATIBLE HARDWARE" ERROR MESSAGE. UPON ACKNOWLEDGING THE MESSAGE, ANOTHER MESSAGE WAS RECEIVED, "TEMPERATURE WARNING", FOLLOWED BY A "SERVICE DUE" MESSAGE. THE ISSUE WAS UNABLE TO BE REMEDIED, SO THE CASE WAS CANCELLED. THERE WAS NO PATIENT INJURY. THE TREATMENT WAS RESCHEDULED AND SUCCESSFULLY COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227784 VISUAL-CE CRYOABLATION SYSTEM CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1