BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEDICS CRYOTIP

    MDR report key: 178443 · Received July 21, 1998

    Report

    Report Number
    1519132-1998-00050
    Event Type
    Malfunction
    Date Received
    July 21, 1998
    Date of Event
    June 2, 1998
    Report Date
    June 26, 1998
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO A CRYOSURGICAL PROCEDURE, THE TIP OF 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, EXO/ENDOCERVICAL GEH CRYOMEDICS, INC. T-1910 TBFU

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR