BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 12806681 · Received November 12, 2021

    Report

    Report Number
    2134265-2021-14141
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 12, 2021
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE. A VISUAL-ICE CRYOABLATION SYSTEM WAS SELECTED FOR USE IN A PROCEDURE WITH FOUR CX NEEDLES. THROUGHOUT THE PROCEDURE, DURING BOTH FREEZE CYCLES, THE TEMPERATURE ON THE TIP OF THE NEEDLE WAS -1.05, WHICH WAS NORMALLY -1.20. CT SHOWED THE ICEBALL TO BE 1CM LESS THAN EXPECTED IN ALL DIMENSIONS. THE SAME ISSUE WAS OBSERVED ON ALL NEEDLES ACROSS ALL CHANNELS. ICE FORMATION WAS SUFFICIENT IN COVERING THE TARGETED TISSUE AFTER THE THIRD FREEZE TO INCREASE THE ICEBALL SIZE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700985 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 V50014 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown