BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8181738 · Received December 19, 2018

    Report

    Report Number
    3008262715-2018-00078
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 20, 2018
    Report Date
    March 1, 2019
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED. SIMULATED USE TESTING CONFIRMED THE REPORTED ISSUE OF SHAFT FROSTING. FURTHER EVALUATION DETERMINED THE SHAFT FROSTING IS DOE TO A VACUUM SLEEVE FAILURE.

    Description of Event or Problem · 1

    SHAFT FROSTING. HOSPITAL CALLED TO REPORT THAT THE OUTSIDE OF THE PROBE WAS NOT INSULATED. PROBE USED IN A PATIENT. NO ADDITIONAL INFORMATION RECEIVED AS OF 12/19/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017210 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. PCS-17 26238

    Patients

    Seq Age Sex Outcome Treatment
    1