BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8588916 · Received May 7, 2019

    Report

    Report Number
    3008262715-2019-00062
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 8, 2019
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE EVALUATED BY SIMULATED USE TESTING WHICH CONFIRMED THE REPORTED ISSUE. DISASSEMBLY AND FURTHER EVALUATION DETERMINED THAT CLOGGING WAS THE CAUSE OF NO/INADEQUATE ICE FORMATION.

    Description of Event or Problem · 1

    PROBE PRE-TESTED, LOOKS FINE. 1ST CYCLE: FREEZE GOES DOWN TO -90C. 2ND CYCLE: FREEZE GOES DOWN TO -90C AND GRADUALLY UP TO -20C WITHIN FEW MINS. 3RD CYCLE: FREEZE GOES DOWN TO -90C AND THEN 0C WITHIN FEW MINS. THAWING HAS BEEN PERFORMED IN BETWEEN CYCLES. ON 2ND CYCLE, DECIDED TO CHANGE TO NEW PROBES AND TEMPERATURE GOES DOWN TO -140C. PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382698 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. RS-24 24249

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR