BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM CHINA

    MDR report key: 12360227 · Received August 24, 2021

    Report

    Report Number
    2134265-2021-10562
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 30, 2021
    Report Date
    October 25, 2021
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS NOT RETURNED FOR ANALYSIS. FIELD REPAIR BEGUN 11AUG2021 AND IS STILL ONGOING. THE PART NEEDED TO COMPLETE THE REPAIR HAS NOT BEEN RECEIVED. THE FIELD AGENT WAS ABLE TO CHECK THE CONSOLE LOG AND REPORTED AN ERROR: '80 - DIGI VOLTAGE POWER CHECK FAILED'. THE WORK ORDER IS STILL OPEN FOR COMPLETION AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT ICE WAS CREATED BY THE CONSOLE. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR USE DURING A CRYOABLATION PROCEDURE. DURING DEVICE PREPARATION, THE DEVICE COULD NOT BE "REFRIGERATED". THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT IS STABLE WITH NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSUFFICIENT ICE WAS CREATED BY THE CONSOLE. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR USE DURING A CRYOABLATION PROCEDURE. DURING DEVICE PREPARATION, THE DEVICE COULD NOT BE "REFRIGERATED". THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT IS STABLE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259854 VISUAL-ICE CRYOABLATION SYSTEM CHINA UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000-03

    Patients

    Seq Age Sex Outcome Treatment
    1