BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1968630 · Received December 23, 2010

    Report

    Report Number
    3005278776-2010-00158
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 26, 2010
    Report Date
    November 28, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (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. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE RED MARKER HAS NO IMPACT ON DEVICE SAFETY AND PERFORMANCE AND THUS THE OUTCOME OF THE PROCEDURE. IT ONLY SERVES AS AN ADDITIONAL INDICATION OF THE SEQUENTIAL STATUS OF DEVICE OPERATION.

    Description of Event or Problem · 1

    OPEN COLORECTAL ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. THE FOLLOWING COMPLAINT WAS REPORTED "WHEN THE SURGEON TURNED THE OPERATION KNOB TO END, THE RED INDICATOR CAME OUT BUT THE DEVICE CAN BE FIRED AND TOOK OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27 43271202

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention