BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL-ICE® CRYOABLATION SYSTEM

    MDR report key: 9106764 · Received September 23, 2019

    Report

    Report Number
    3004462490-2019-00006
    Event Type
    Injury
    Date Received
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    GALIL MEDICAL LTD
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS CASE FROM THE PHYSICIAN UNSUCCESSFULLY. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO DEVICE MALFUNCTION WAS REPORTED. THE DEVICE AS A CONTRIBUTING FACTOR TO THIS EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SOFT TISSUE CHEST WALL ABLATION OF A HEPATOCELLULAR CARCINOMA (HCC) METASTASIS. AT THE 6 MONTH POST-ABLATION SCAN, IT WAS THE PHYSICIAN'S OPINION THAT THERE WAS NO RESULT AND THAT IT LOOKED LIKE NO TREATMENT HAD BEEN PERFORMED. DUE TO THIS, THE PATIENT REQUIRED ADDITIONAL TREATMENT. THIS EVENT WAS REPORTED TO THE BTG CLINICAL SPECIALIST DURING AN UNRELATED CASE. NO DEVICE MALFUNCTION WAS REPORTED TO BTG AT THE TIME OF THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896787 VISUAL-ICE® CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL LTD FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other