BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2050770 · Received March 31, 2011

    Report

    Report Number
    3005278776-2011-00019
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 19, 2011
    Report Date
    March 4, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD,
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE RING WAS RETURNED AND INVESTIGATED. NO MALFUNCTION OR FAILURE WAS DETECTED AND THE RING WAS FOUND TO BE WITHIN ITS SPECIFICATION. ANASTOMOTIC LEAKAGE IS AN ANTICIPATED COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES AND THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES.

    Description of Event or Problem · 1

    PT UNDERWENT OPEN LAR DUE TO DIVERTICULITIS. ANASTOMOSIS WAS CREATED USING THE COLONRING DEVICE. PT WAS DISCHARGED ON POD 4, HAD A BOWEL MOVEMENT AT HOME AND IMMEDIATELY HAD LLQ (LEFT LOWER QUARTER) DISCOMFORT AND PAIN. THE PT CAME TO ER ON THE EVENING OF POD 5 AND WAS FOUND TO HAVE NORMAL WBC AND NO FEVER, BUT REBOUND IN LLQ. THE PT WAS ADMITTED FOR OBSERVATION AND ON NEXT DAY HAD FEVER AND ELEVATED WBC COUNTS. ON POD 6, THE SURGEON TOOK THE PT BACK TO OPERATING ROOM AND PERFORMED A COLOSTOMY.

    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 43271231

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention