BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1910582 · Received November 19, 2010

    Report

    Report Number
    3005278776-2010-00150
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    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 RECEIVED FOR EVALUATION AND NO INFO IS AVAILABLE REGARDING ITS SERIAL NUMBER. IN ADDITION, THE AVAILABLE INFO REGARDING THE PT OR THE PROCEDURE IS VERY LIMITED AND THEREFORE, NO FURTHER CONCLUSIONS COULD BE DRAWN. IN THOUSANDS OF PROCEDURES PERFORMED WITH THE DEVICE, THE RING HAS BEEN REPORTED TO BE RETAINED ONLY IN A VERY FEW CASES. THE COMPANY'S GENERAL RECOMMENDATION IN SUCH CASES IS TO HAVE THE RING REMOVED IF IT WAS NOT EXPELLED WITHIN 4 WEEKS.

    Description of Event or Problem · 1

    ANASTOMOSIS WITH THE COLONRING WAS CREATED IN A PT WHO UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE DUE TO RECTAL MALIGNANCY. IT WAS DETECTED BY X-RAY THAT THE COLONRING WAS STILL HANGING ON THE WALL OF COLON 40 DAYS AFTER THE PROCEDURE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention