BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1656190 · Received March 31, 2010

    Report

    Report Number
    3005278776-2010-00036
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    NITI MEDICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE IMPORTER (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 PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECS. THE DEVICE WAS NOT RETURNED FOR EVAL. ACCORDING TO THE SURGEON, THE MISFIRING WAS DUE TO WRONG OPERATION OF THE DEVICE AND NOT DUE TO A FAILURE IN THE DEVICE.

    Description of Event or Problem · 1

    THE DEVICE MISFIRED DUE TO USER OPERATION MISTAKE. THE DEVICE WAS REPLACED WITH A NEW CAR AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention