BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE, IR, 1.7MM

    MDR report key: 1930244 · Received November 18, 2010

    Report

    Report Number
    3008262715-2010-00093
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    HEALTHTRONICS INC
    Product Code
    GEH
    PMA / PMN Number
    K060279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY REPORTED.

    Description of Event or Problem · 1

    DURING TESTING, THE TECH'S AND DOCTOR NOTICED THAT THE FROST WAS COMING ALL THE WAY UP THE PROBE SHAFT. NO PT CONTACT, PROBE NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE CRYOPROBE, IR, 1.7MM UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS INC PERC-17 2343

    Patients

    Seq Age Sex Outcome Treatment
    1