BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMSIS RING (CAR 27)

    MDR report key: 1656129 · Received March 31, 2010

    Report

    Report Number
    3005278776-2010-00054
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    January 1, 2009
    Report Date
    May 5, 2009
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. NITI HAS RE-EVALUATED THIS EVENT DURING A RETROSPECTIVE REVIEW, AND HAS DETERMINED THE EVENT TO BE MDR REPORTABLE. THE DEVICE HISTORY FILE WAS REVIEWED AND INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO ITS SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    AFTER COMPLETION OF A SUCCESSFUL ANASTOMOSIS PROCEDURE WITH THE CAR, THE RED MARKER FELL FROM THE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27 43271133

    Patients

    Seq Age Sex Outcome Treatment
    1