BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8170955 · Received December 17, 2018

    Report

    Report Number
    3008262715-2018-00072
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 21, 2018
    Report Date
    November 21, 2018
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY SIMULATED USE TESTING. VACUUM SLEEVE FAILURE WAS THE CAUSE OF THE SHAFT FROSTING.

    Description of Event or Problem · 1

    SEVEN CRYOPROBES FAILED PRE-TEST DURING THE SAME CASE. ALL FROM THE SAME LOT NUMBER. COMPLAINT 6 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011691 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. PCS-17 26054

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR