BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8178871 · Received December 19, 2018

    Report

    Report Number
    3008262715-2018-00081
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 27, 2018
    Report Date
    January 22, 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

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS REVIEWED WITH NO ISSUES FOUND.

    Description of Event or Problem · 1

    2 PROBES PASSED PRETEST. DURING THE TREATMENT PHASE, THE SHAFTS FROSTED AND CAME IN CONTACT WITH THE SKIN. PROBES DISPOSED OF AT THE HOSPITAL. COMPLAINT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016981 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. PCS-17 25797

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR