BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 8066280 · Received November 13, 2018

    Report

    Report Number
    3008262715-2018-00043
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 18, 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

    ISSUE IDENTIFIED DURING PRETESTING. NO PATIENT CONTACT. REPLACEMENT PROBES USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    FOUR PROBES FROSTED UP THE SHAFT DURING PRETESTING. USED OTHER PROBES TO COMPLETE THE CASE. COMPLAINT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905609 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. PCS-17 26054

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR