BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS MEDICAL

    MDR report key: 2588459 · Received May 18, 2012

    Report

    Report Number
    MW5025481
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 9, 2012
    Report Date
    May 18, 2012
    Manufacturer
    ATS MEDICAL INC
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MAZE PROCEDURE WOULDN'T WORK BECAUSE THE MD SAID IT NEVER GOT COLD ENOUGH. SOMETHING WASN'T WORKING RIGHT. NEXT CORD BOX WE OPENED WORKED PROPERLY AND COOLED PROPERLY TO DO THE PROCEDURE EFFICIENTLY. THE FIRST ONE WASN'T ACTUALLY USED ON PATIENT, WE TESTED IT OUT PRIOR TO ACTUAL USE, SO JUST A NEAR MISS. ATS CRYOMAZE CLAMP AND SURGICAL ABLATION PROBEREF 60M1 SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL ATS CRYOMAZE CLAMP AND SURGICAL ABLATION PROBE OCL ATS MEDICAL INC 60CM1 25011044

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR