BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZE LINEAR CRYOSURGICAL DISPOSABLE PROBE

    MDR report key: 2130695 · Received June 16, 2011

    Report

    Report Number
    3003502395-2011-00009
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEH
    PMA / PMN Number
    K111042
    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).THE DEVICE IS EN ROUTE BACK TO ATRICURE. AN EVALUATION OF THE DEVICE WILL BE DONE UPON RECEPTION. (B)(4)

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INSPECTED AND PERFORMED PER SPECIFICATIONS. THE TIP WAS REVIEWED UNDER A MICROSCOPE AND A SMALL VOID COULD BE SEEN IN THE EPOXY. THE TIP WAS SECTIONED AND AVOID BETWEEN THE PLUG AND THE OUTER FORM OF EPOXY WAS REVEALED. EACH COMPONENT IS 100% VISUALLY INSPECTED AND 100% PRESSURE TESTED ( A MINIMUM OF 2 TIMES THROUGH ASSEMBLY). THIS FAILURE MODE DOES NOT IMPEDE PERFORMANCE OF THE DEVICE AND POSES NO RISK TO THE PATIENT. THIS IS THE FIRST INSTANCE THAT THIS FAILURE MODE HAS BEEN OBSERVED.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6) 2011 AN ATRICURE MAZE LINEAR CRYOSURGICAL DISPOSABLE PROBE WAS USED. DURING IMPLEMENTATION THE PHYSICIAN NOTICED A LEAK IN THE DISTAL TIP OF THE PROBE CAUSING NITROUS OXIDE TO BE INTRODUCED INTO AN OPEN ATRIUM. THE PATIENT WAS PROACTIVELY GIVEN ANTIBIOTICS AND THE PROCEDURE WAS FINISHED WITH A NEW CRYO2 PROBE. THERE WAS NO LONG TERM PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAZE LINEAR CRYOSURGICAL DISPOSABLE PROBE UNIT, CRYOSURGICAL, ACCESORIES GEH ATRICURE, INC. CRYO2 29337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other