BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2130581 · Received June 14, 2011

    Report

    Report Number
    3005278776-2011-00033
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    May 16, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    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 LTD; 3005278776) AND (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT AVAILABLE FOR EVAL. HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECIFICATIONS. NO CONCLUSIONS COULD BE DRAWN BASED ON THE LIMITED INFO THAT IS CURRENTLY AVAILABLE. IT SHOULD BE NOTED THAT COMPLICATIONS SUCH AS STRICTURES OR STENOSES ARE ANTICIPATED COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES.

    Description of Event or Problem · 1

    THE PT UNDERWENT A CLOSURE OF COLOSTOMY PROCEDURE. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. THE FOLLOWING WAS REPORTED: "THE COLONRING DID NOT DISCHARGE, THAT CAUSES A STENOSIS. TWO TIMES GLUING OF THE ANASTOMOSIS, AT LAST STEP, PERFORMING OF A HARTMAN PROCEDURE."

    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) 43271228

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention