BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICEROD MRI NEEDLE

    MDR report key: 2860147 · Received November 21, 2012

    Report

    Report Number
    9616793-2012-00031
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    OCL
    PMA / PMN Number
    K051052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THREE (3) ICERODS WERE INSERTED TO A RCC OF 4CM IN DIAMETER AFTER THE NEEDLE TESTS IN WHICH NO MALFUNCTION WAS FOUND. RADIOLOGIST FOUND A QUITE SMALL FROZEN AREA AROUND ALL OF THE NEEDLES DURING FREEZING AND ADDED 2 ICESEEDS TO THE RCC EXPECTING TO HELP WITH THE FREEZING. BUT THE FROZEN AREA OF 8 OR 9 MM DIAMETER AROUND EACH NEEDLE WAS SEEN IN THE CT IMAGE. THE RADIOLOGIST ABORTED THE ABLATION. NO ADVERSE EVENT WAS IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICEROD MRI NEEDLE CRYOSURGICAL UNIT, ACCESSORIES OCL GALIL MEDICAL LTD. FPRPR3193 N9697

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK