BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1966278 · Received January 18, 2011

    Report

    Report Number
    3005278776-2010-00164
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 19, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; (B)(4)); AND THE IMPORTER ((B)(4)), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVAL AND THERE IS NO INFO REGARDING THE DEVICE LOT/SERIAL NUMBER, THEREFORE, NO CONCLUSION COULD BE DRAWN BASED ON THE VERY LIMITED INFO WE HAVE REGARDING THIS EVENT. ANASTOMOTIC LEAKAGE, IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES WITH BOTH STAPLERS AND COMPRESSION ANASTOMOSIS DEVICES. THE CURRENT CUMULATIVE LEAK RATE FOLLOWING USE OF COLONRING DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. PT'S CO-MORBIDITIES SUCH AS DIABETES AND OBESITY ARE KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE.

    Description of Event or Problem · 1

    A PT UNDERWENT LOW ANTERIOR RESECTION DUE TO A COLON MALIGNANCY USING THE COLONRING DEVICE. THE PROCEDURE STARTED AS A LAPAROSCOPIC PROCEDURE THAT HAS CONVERTED TO OPEN PROCEDURE DUE TO COMPLICATIONS CAUSED BY HOLES IN THE RIGHT INTESTINE. ON POD 2, THE PT HAD FEVER AND PERITONITIS. THE PT WAS REOPERATED, STOMAS HAVE BEEN CONDUCTED FROM BOTH STAMPS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention