BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE, V-PROBE 2.4MM ATTACHED

    MDR report key: 1930253 · Received November 18, 2010

    Report

    Report Number
    3008262715-2010-00091
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 28, 2010
    Manufacturer
    HEALTHTRONICS, INC
    Product Code
    GEH
    PMA / PMN Number
    K101333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY REPORTED. FOLLOW-UP MDR WILL BE SUBMITTED ONCE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    DURING PRETEST, PROBE HAD ICE FORM ALONG THE ENTIRE LENGTH OF THE SHAFT PAST THE 4.0CM SET POINT. PROBE WAS REPLACED. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE, V-PROBE 2.4MM ATTACHED UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC CVA2400 09-0747

    Patients

    Seq Age Sex Outcome Treatment
    1