BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE C/PROBE 2.4 VARIABLE ATTACHE

    MDR report key: 1925817 · Received November 8, 2010

    Report

    Report Number
    3008262715-2010-00088
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 14, 2010
    Manufacturer
    HEALTHTRONICS INC
    Product Code
    GEH
    PMA / PMN Number
    K101333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SHAFT FROSTED ALL THE WAY UP THE HANDLE DURING PRE-TEST. PROBE WAS REPLACED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE C/PROBE 2.4 VARIABLE ATTACHE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS INC CVA2400 2817

    Patients

    Seq Age Sex Outcome Treatment
    1