BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS MEDICAL

    MDR report key: 2614822 · Received June 7, 2012

    Report

    Report Number
    MW5025751
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    April 9, 2012
    Report Date
    June 7, 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

    ABLATION PROBE WOULD NOT GET COLD ENOUGH FOR PHYSICIAN TO PERFORM PROCEDURE. TESTED PROBE PRIOR TO USE, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL ATS CRYOMAZE CLAMP OCL ATS MEDICAL INC. 60CM! 25011044
    2 ATS MEDICAL SURGICAL ABLATION PROBE OCL ATS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR