BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEDICS CRYOTIP

    MDR report key: 159606 · Received March 24, 1998

    Report

    Report Number
    1519132-1998-00006
    Event Type
    Malfunction
    Date Received
    March 24, 1998
    Report Date
    March 10, 1998
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXAMINED AND SHOWED SIGNS OF INTERFACE CORROSION. THE ACTION TAKEN BY CABOT MEDICAL IN SEPTEMBER 1989, AS DESCRIBED IN THE ORIGINAL MDR SUBMISSION DATED 3/10/98, WAS DONE TO PREVENT THIS CONDITION FROM OCCURRING.

    Description of Event or Problem · 1

    PRIOR TO A CRYOSURGICAL PROCEDURE THE CRYOTIP SEPARATED UPON PRESSURIZATION OF THE CRYOGUN. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMEDICS CRYOTIP CRYOSURGICAL PROBE, GENERAL PURPOSE GEH CRYOMEDICS, INC. T-0819 TCFK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN