BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1762915 · Received June 30, 2010

    Report

    Report Number
    3004114958-2010-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 2, 2010
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K063644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER PLACED DEVICE HANDLE IN CLOSE PROXIMITY TO A HEATING ELEMENT, WHICH LIKELY CAUSED THE CO2 CYLINDER WITHIN TO EXCEED PRESSURE LIMITS, RESULTING IN THE MALFUNCTION OF THE DEVICE. CARDICA REPRESENTATIVE UNSUCCESSFULLY MADE TWO IN-PERSON ATTEMPTS TO RECOVER THE DEVICE. EVAL RESULTS: PRODUCT SUBJECTED TO ABNORMAL ENVIRONMENTAL CONDITIONS BASED UPON ANECDOTAL INFO FROM THE SITE.

    Description of Event or Problem · 1

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM WAS PLACED IN A WATER BATH WITH THE HANDLE IN PROXIMITY TO A HEATER. THE DEVICE RUPTURED, CAUSING, "SOMETHING TO SHOOT ACROSS THE ROOM." THERE WAS NO REPORT OF INJURY OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT XA DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1