BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 1950231 · Received December 10, 2010

    Report

    Report Number
    3008262715-2010-00098
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    HEALTHTRONICS, INC
    Product Code
    GEH
    PMA / PMN Number
    K060279
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY REPORTED.

    Description of Event or Problem · 1

    PROBE WAS TESTED AND APPEARED TO BE O.K. (PASSED TEST). PROBE STARTED FROSTING UP THE SHAFT BETWEEN 2-3 MINUTES DURING THE FIRST FREEZE. PROBE WAS TURNED OFF AND THE REST OF THE ABLATION WAS COMPLETED USING THE SECOND PROBE THAT HAD BEEN PLACED. (THERE WERE A TOTAL OF 2 PROBES INSERTED, AND THE LESION WAS SMALL ENOUGH TO COMPLETE THE ABLATION USING JUST ONE PROBE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC PERC-24 09-0605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other