BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM

    MDR report key: 8153379 · Received December 11, 2018

    Report

    Report Number
    3008262715-2018-00066
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 2, 2019
    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

    Description of Event or Problem · 1

    UNIT WAS UNPLUGGED BY A STAFF MEMBER OF THE OPERATING ROOM UNINTENTIONALLY THINKING IT WAS FROM A DIFFERENT DEVICE AND AFTER SEVERAL HOURS OF TROUBLESHOOTING WITH AN ENDOCARE SERVICE REPRESENTATIVE WE STILL COULDN'T GET THE UNIT UP AND RUNNING, RESULTING IN CANCELLATION OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993646 ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. CRYO-CS-3 08-0475

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR