BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE 1.7MM RIGHT ANGLE

    MDR report key: 2933875 · Received January 29, 2013

    Report

    Report Number
    3008262715-2013-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    HEALTHTRONICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K011074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY REPORTED. PROBE RETURNED TO MANUFACTURER AND EVALUATED. REPORTED DISCREPANCY COULD NOT BE DUPLICATED. RETURNED PROBE MET ALL MANUFACTURING SPECIFICATIONS.SERVICE TECHNICIAN SENT OUT TO HOSPITAL TO CHECK THE CRYO-CS UNIT (CSL 1024). COULD NOT GET SPECIFICS ON ORIGINAL PROBLEM. COMPLETED ANNUAL PM, UNIT OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    AT THE TIME OF FREEZING, COULD NOT MAINTAIN PROPER TEMPERATURE - COMPLETE SHUTDOWN AND MULTIPLE PROBE CONNECTION CHANGES NEEDED. THE PROBE KEPT DISENGAGING AND AFTER EACH FUNCTION CHANGE, THE DOCTOR WOULD NEED TO CHANGE PORTS TO GET THE PROBE TO FUNCTION PROPERLY, 60 MINUTE DELAY IN CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38547 ENDOCARE CRYOCARE CRYOPROBE 1.7MM RIGHT ANGLE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC. PERC-17 9602

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR