BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE CRYOPROBE

    MDR report key: 1834508 · Received September 10, 2010

    Report

    Report Number
    3008262715-2010-00069
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 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 REQUESTS FOR PATIENT UPDATE.

    Description of Event or Problem · 1

    WARMER APPEARED TO BE WORKING CORRECTLY AT FIRST FREEZE, BUT THE FLOW WHEEL WAS MOVING SLOWER DURING THE FIRST THAW CYCLE. BAG PRESSURE HAD DROPPED TO BELOW 150MM AND THE FLUID LEVEL WAS DROPPING QUICKLY. THE WARMER WAS INSPECTED IN THE PATIENT AND WARM FLUID APPEARED TO BE LEAKING OUT. THE WARMER WAS SHUT OFF AND ANOTHER WAS BROUGHT IN AND PREPPED FOR USE, A PROCESS TAKING ABOUT 6 MINUTES. THE FLUID WAS DOWN TO 250CCS AND THE DEFECTIVE WARMER WAS REMOVED. IT APPEARED TO BE "SHREDDED" AND TORN OPEN, LOOKING FRAYED. A CYSTOSCOPY WAS PERFORMED ON THE PATIENT AND DR (B)(6) REMARKED THE URETHRA APPEARED "ABRADED". HE DECIDED TO TAKE A LOOK AT THE PROSTRATE AND FINALIZED HIS DECISION TO ABORT THE PROCEDURE AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS INC CRYO 60 (206VKIT) 2182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other