BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8037839 · Received November 5, 2018

    Report

    Report Number
    3008262715-2018-00052
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 9, 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

    EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CRYOPROBE FROSTED UP THE SHAFT DURING PRE-TESTING. A DIFFERENT PROBE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876675 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. PCS-17R 25752

    Patients

    Seq Age Sex Outcome Treatment
    1