BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTIP

    MDR report key: 18707 · Received January 4, 1995

    Report

    Report Number
    MW1004646
    Event Type
    Malfunction
    Date Received
    January 4, 1995
    Date of Event
    November 1, 1994
    Report Date
    January 3, 1995
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING WARM-UP PROCEDURES ON TWO DIFFERENT OCCASIONS, THE TIPS BLEW APART. THE RPTR IS CONCERNED WITH THE CONSEQUENCES IF THE INCIDENTS HAD OCCURRED WHEN THE DEVICE WAS BEING USED ON PTS. THE TIPS WERE PROBABLY PURCHASED IN THE MID TO LATE 80'S. THE RPTR STATED THAT THE HOSP HAS CLEANING PROCEDURES BUT NO DIRECTIVE FROM THE MFR THAT THE TIPS NEED TO BE INSPECTED EVERY THREE YEARS AS HE WAS RECENTLY TOLD. THE TIPS ARE USED ON A NITROUS OXIDE CRYO GUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOTIP GEH CRYOMEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * MODEL MT-700, PRODUCT 90351