BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1980228 · Received February 1, 2011

    Report

    Report Number
    3005278776-2011-00001
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 2, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 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

    PATIENT SUFFERING OF COLON MALIGNANCY UNDERWENT LAPAROSCOPIC LAR, ANASTOMOSIS WAS PERFORMED USING THE COLONRING DEVICE. ON POD 3, PATIENT HAD HIGH FEVER AND TENDER ABDOMEN. CT SCAN REVEALED ANASTOMOTIC LEAKAGE. RING WAS REMOVED AND HARTMAN PROCEDURE WAS CONDUCTED FOLLOWED BY ANTIBIOTIC TREATMENT.

    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 43001006

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention ALPRAZOLAM| ESTRADIOL| THYROXINE