BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICESEED CRYOABLATION NEEDLE

    MDR report key: 11049497 · Received December 21, 2020

    Report

    Report Number
    2134265-2020-18053
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    January 1, 2020
    Report Date
    December 21, 2020
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE TO REPORT. IF FURTHER RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE OF EVENT: EVENT DATE IS UNKNOWN. EVENT DATE IS ENTERED AS YEAR THE ARTICLE WAS PUBLISHED. EXTERKATE, L., PETERS, M., SOMFORD, D. M., & VERGUNST, H. (2020). FUNCTIONAL AND ONCOLOGICAL OUTCOMES OF SALVAGE CRYOSURGERY FOR RADIORECURRENT PROSTATE CANCER. BJU INTERNATIONAL, 1,11. HTTPS://DOI.ORG/10.1111/BJU.15269.

    Description of Event or Problem · 1

    LITERATURE REVIEW. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. THIS STUDY EVALUATED THE ONCOLOGICAL AND FUNCTIONAL OUTCOMES OF SALVAGE CRYOSURGERY (SCS) FOR RADIORECURRENT PROSTATE CANCER (RRPCA). THE ICEROD CRYOABLATION NEEDLE WAS A DEVICE REFERENCED WITHIN THE STUDY. URINARY INCONTINENCE, ERECTILE DYSFUNCTION, FISTULA, THROMBOEMBOLISM, HEMATURIA, URINARY TRACT INFECTION, ACUTE APPENDICITIS, URETHRAL SLOUGHING, AND STENOSIS WERE NOTED TO HAVE OCCURRED. SURGICAL PROCEDURES INCLUDING URETHROTOMY, CYSTOPROSTATECTOMY, AND TRANSURETHRAL RESECTION OF THE PROSTATE WERE ALSO NOTED AS PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510808 ICESEED CRYOABLATION NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention