BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSURGICAL, ACCESSORIES

    MDR report key: 11805658 · Received May 11, 2021

    Report

    Report Number
    2134265-2021-06037
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 11, 2021
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE WAS NOT REPORTED AND APPROXIMATED (B)(6) 2021, FIRST DAY OF THE MONTH THE ABSTRACT WAS REVIEWED. CITATION: FERNANDEZ PASCUAL, E., QUINTANA FRANCO, L., MARTINEZ-BALLESTEROS, C., LINARES ESPINOS, E., MARTIN VIVAS, C., CASTILLO, E., BIANCO, F., & MARTINEZ-SALAMANCA, J. (2020). ONCOLOGICAL AND FUNCTIONAL OUTCOMES OF IMAGE-GUIDED CRYOTHERAPY FOR THE TREATMENT OF LOCALISED PROSTATE CANCER: RESULTS FROM A HIGH-VOLUME CENTRE. EUROPEAN UROLOGY OPEN SCIENCE, 19, E1335-E1336. HTTPS://DOI.ORG/10.1016/S2666-1683(20)33479-0.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA ABSTRACT THAT CONTINENCE, VOIDING AND ERECTILE FUNCTION OCCURRED. THE PURPOSE OF THE ABSTRACT WAS A REVIEW IF TREATMENT OF LOCALIZED PROSTATE CANCER USING IMAGE-GUIDED CRYOTHERAPY (CT) IS BECOMING AN EFFECTIVE AND SAFE TREATMENT OPTION IN ONCOLOGICAL AND FUNCTIONAL TERMS. RETROSPECTIVE STUDY OF IMAGE-GUIDED CT PROCEDURES, PERFORMED BETWEEN 2015-2018. NINETY-SIX PATIENTS UNDERWENT IMAGE-GUIDED CT USING GALIL SYSTEM (CRYOABLATION NEEDLES AND CONTROL UNIT) IN THIS PERIOD. DURING FOLLOW-UP IT WAS FOUND PATIENTS EXPERIENCED WORSENED ISSUES WITH CONTINENCE, VOIDING AND ERECTILE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703200 CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention