BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2229429 · Received August 19, 2011

    Report

    Report Number
    3005278776-2011-00043
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 21, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS (B)(4)) AND THE IMPORTER (NITI SURGICAL SOLUTIONS (B)(4)), AS NITI SURGICAL SOLUTIONS (B)(4) SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER INFO REGARDING THE DEVICE OR THE PT IS AVAILABLE. ANASTOMOTIC LEAKAGE IS AN ANTICIPATED COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES WITH NO RELATION TO THE METHOD USED FOR THE CREATION OF THE ANASTOMOSIS. THE CURRENT CUMULATIVE LEAK RATE ASSOCIATED WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR OTHER METHODS. ADDITIONAL APPLICABLE 510 (K) IS: K062008.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY DUE TO DIVERTICULAR DISEASE. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. ACCORDING TO THE REPORT, THE PT DISCHARGED HOME ON POD 7 AND RETURNED THE DAY AFTER WITH MASSIVE ABDOMINAL PAIN. A FULL DEHISCENCE WAS DIAGNOSED AND A HARTMANN PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. COLONRING (CAR27)

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R