BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8037847 · Received November 5, 2018

    Report

    Report Number
    3008262715-2018-00047
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    July 15, 2017
    Report Date
    November 9, 2018
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER INITIAL REPORTER, THE HOSPITAL REFUSED TO REPORT PATIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY SIMULATED USE TESTING WHICH CONFIRMED THE REPORTED ISSUE OF SHAFT FROSTING AND DETERMINED THE CAUSE TO BE VACUUM SLEEVE FAILURE.

    Description of Event or Problem · 1

    THE ENTIRE PROBE SHAFT FROSTED DURING PRETEST AT FIRST USE. THE PATIENT WAS NOT UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876665 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. RS-17L 21610

    Patients

    Seq Age Sex Outcome Treatment
    1