BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMAZE

    MDR report key: 1982006 · Received January 7, 2011

    Report

    Report Number
    1982006
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    CONNECTION ON ATS CRYOMAZE PROBE BROKE WHILE ATTEMPTING TO CONNECT TO CRYO UNIT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SEE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMAZE PROBE, ABLATION, CARDIAC, SURGICAL OCL ATS MEDICAL, INC. 60SF2 P/N: 3317-000 REV-A

    Patients

    Seq Age Sex Outcome Treatment
    1 *