BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1638161 · Received March 21, 2010

    Report

    Report Number
    3005278776-2010-00023
    Event Type
    Malfunction
    Date Received
    March 21, 2010
    Report Date
    March 20, 2010
    Manufacturer
    NITI MEDICAL TECHNOLOGIES LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; (B)(4)) AND THE IMPORTER (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, THE PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECIFICATIONS. THE RED MARKER HAS NO INFLUENCE ON THE DEVICE FUNCTIONALITY OR THE OUTCOME OF THE PROCEDURE. IT IS ONLY AN ADDITIONAL INDICATOR OF THE SEQUENTIAL STATUS OF DEVICE OPERATION.

    Description of Event or Problem · 1

    WHEN THE CUSTOMER REMOVED THE CAR INSTRUMENT FROM THE PACKAGE, THE RED INDICATOR FELL OUT OF THE DEVICE. THE DEVICE WAS USED WITHOUT THE RED BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI MEDICAL TECHNOLOGIES LTD. CAR 27 43271204

    Patients

    Seq Age Sex Outcome Treatment
    1