BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYO 4000 AND CRYO PROBE 4010

    MDR report key: 374854 · Received January 29, 2002

    Report

    Report Number
    1218813-2002-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2002
    Date of Event
    December 19, 2001
    Report Date
    January 18, 2002
    Manufacturer
    MIRA, INC.
    Product Code
    HQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON TWO SEPARATE OCCASIONS DR. EXPERIENCED A MALFUNCTION OF THE CR4000 CRYO UNIT AND CR4010 CRYO PROBE. AFTER TURNING THE UNIT ON AND ACTIVATING THE FOOTSWITCH, THE PROBE UNEXPECTEDLY RELEASED FROM THE UNIT. THE FORCE WAS SIGNIFICANT. THE SECOND INCIDENT OCCURRED WHILE A PATIENT WAS UNDERGOING TREATMENT. WHILE HOLDING THE PROBE, THE DOCTOR'S HAND WAS FORCED FORWARD BY THE PRESSURE OF THE RELEASED PROBE CAUSING MINOR DAMAGE TO THE PATIENTS CONJUNCTIVA. THE PATIENT WAS SUCCESSFULLY TREATED WITH A BACKUP UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO 4000 AND CRYO PROBE 4010 OPHTHALMIC CRYO PROBE HQA MIRA, INC. CR 4000, CR 4010 13-0901 (CR4010)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other