BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZE LINEAR CARDIAC PROBE

    MDR report key: 2222211 · Received August 24, 2011

    Report

    Report Number
    3003502395-2011-00010
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEH
    PMA / PMN Number
    K811390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6) 2011, A MAZE LINEAR CARDIAC REUSABLE PROBE WAS CONNECTED TO A CCS-200 CRYOSURGICAL SYSTEM. AFTER THE FIRST ABLATION CYCLE OF 60 SECONDS THE PROBE WAS DEFROSTED. DURING REPOSITIONING A "HISS" WAS HEARD AND THE PHYSICIAN REMOVED THE PROBE. AFTER VISUAL EXAMINATION THE PHYSICIAN NOTICED THE PROBE BOILER (TIP) SEPARATED FROM THE HANDLE. THE TIP WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS FINISHED WITH A DISPOSABLE PROBE WITHOUT INCIDENT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAZE LINEAR CARDIAC PROBE UNIT, CRYSOSURGICAL, ACCESSORIES GEH ATRICURE, INC. 3011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other