BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8066303 · Received November 13, 2018

    Report

    Report Number
    3008262715-2018-00049
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 28, 2018
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CONFIRMED THE REPORTED ISSUE OF SHAFT FROSTING. FURTHER EVALUATION REVEALED A VACUUM SLEEVE FAILURE WAS THE CAUSE.

    Description of Event or Problem · 1

    SHAFT FROSTING DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902536 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. RS-17 24073

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR