BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 1834509 · Received September 10, 2010

    Report

    Report Number
    3008262715-2010-00070
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    HEALTHTRONICS INC.
    Product Code
    GEH
    PMA / PMN Number
    K101333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR TESTING. NO RESPONSE TO REQUEST FOR PATIENT UPDATE.

    Description of Event or Problem · 1

    FIRST FREEZE WAS FUNCTIONING NORMALLY AT 2 MIN, AND 5:30 MIN WITH FLOW WHEEL MOVING. AT 7 MIN THE FLOW WHEEL WAS NOT MOVING BUT THE TUBING FELT WARM. A CHECK FOR KINKS IN THE TUBING WAS PERFORMED AND NONE FOUND. WE IMMEDIATELY STOPPED FREEZING AND STARTED THAWING. AT THIS POINT, THE WARMING CATHETER WAS FROZEN TO THE URETHRA. WE LET THE GLAND THAW AND IRRIGATED THE CATHETER USING WARM FLUID TO THE BLADDER THROUGH THE OPENING IN THE TOP OF THE CATHETER. AT 6 MIN OF THAWING, THE CATHETER CAME OUT OF THE PATIENT. A CYSTOSCOPY WAS PERFORMED AND NO VISIBLE DAMAGE WAS OBSERVED. A NEW WARMING CATHETER WAS INSERTED AND THE SECOND FREEZE THAW CYCLE WAS PERFORMED. THE FACILITY WOULD NOT ALLOW THE REMOVAL OF THE CONTAMINATED WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS INC. CRYO 60 (206VKIT) 10-0084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other