BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE® CRYOABLATION SYSTEM

    MDR report key: 7111217 · Received December 12, 2017

    Report

    Report Number
    3004462490-2017-00010
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 12, 2017
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    GALIL MEDICAL TECH SUPPORT IN ISRAEL DISCUSSED THE ISSUE WITH THE CUSTOMER AND DETERMINED THE ISSUE WAS RELATED TO THE PM PARTS. GALIL MEDICAL SENT A NEW PM KIT TO THE CUSTOMER. THE CUSTOMER INSTALLED THE PM KIT. FOLLOW-UP TESTING SHOWED THE SYSTEM PERFORMED AS EXPECTED. THE FAILED PM KIT WAS RETURNED TO GALIL FOR FURTHER INVESTIGATION. INVESTIGATION SHOWED DESICCANT DUST CLOGGING THE TUBE OUTLET FILTER CAUSING LOW GAS FLOW THROUGH MOST CHANNELS RESULTING IN SMALL ICE FORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE PHYSICIAN CHECKED THE ICE-BALL SIZE DURING PROCEDURE THROUGH ULTRASOUND, THE ICE-BALL SIZE SEEMED A LOT SMALLER THAN USUAL. AFTER FINISHING THE PROCEDURE, THE PHYSICIAN AGAIN CHECKED THE ICE-BALL SIZE ON THE CT SCAN AND CONFIRMED THAT THE ICE-BALL SIZE WAS DISTINCTLY SMALL. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS NOT SUCCESSFUL, BECAUSE ICE-BALL WAS NOT MADE WELL. THE PATIENT WAS UNDER LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887573 VISUAL-ICE® CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1