BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CRYOABLATION SYSTEM

    MDR report key: 12359751 · Received August 24, 2021

    Report

    Report Number
    2134265-2021-10654
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 24, 2021
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRO CODE (PRODUCT CODE): OCL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSOLE CREATED INSUFFICIENT ICE. AN UNKNOWN BOSTON SCIENTIFIC CRYOABLATION SYSTEM WAS IN USE IN CONJUNCTION WITH TWO ICEROD NEEDLES. TESTING WAS PERFORMED SUCCESSFULLY AND THE PROCEDURE PROCEEDED. SIX MINUTES INTO THE SECOND FREEZE AN ICEBALL FORMED, HOWEVER, IT AS NOT AS WELL DEFINED, LARGE OR DENSE AS WAS EXPECTED BY THE PHYSICIAN. THE NOISE OF THE GAS SUPPLY SOUNDED "UNDERPOWERED". A THIRD FREEZE WAS CONDUCTED AS A PRECAUTION. ONLY 50 BAR PRESSURE WAS ACHIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256545 UNKNOWN CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1