BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2401015 · Received December 29, 2011

    Report

    Report Number
    3005278776-2011-00060
    Event Type
    Injury
    Date Received
    December 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 30, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS, LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS, LTD.; (B)(4)) AND THE IMPORTER (NITI SURGICAL SOLUTIONS, INC; (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 NO ADD'L INFO IS AVAILABLE. NO CONCLUSIONS COULD BE DRAWN BASED ON THE AVAILABLE INFO. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS 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.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE DUE TO DIVERTICULAR DISEASE. THE ANASTOMOSIS WAS CREATED WITH THE COLONRING DEVICE. ON DAY 5, THE PT UNDERWENT RE-OPERATION AND COMPLETE DEHISCENCE WAS SEEN.

    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 53 YR