BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2230659 · Received August 12, 2011

    Report

    Report Number
    3005278776-2011-00041
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS (B)(4)) AND THE IMPORTER (NITI SURGICAL SOLUTIONS (B)(4)), AS NITI SURGICAL SOLUTIONS (B)(4) 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 ACCORDING TO ITS SPECIFICATIONS. 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 ANASTOMOTIC CREATION METHODS. FURTHERMORE, IT WAS INDICATED THAT THE PT IS DIABETIC, A CONDITION WHICH IS KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE. THE APPLICABLE 510 (K)S ARE: K062008.

    Description of Event or Problem · 1

    THE PT, SUFFERING FROM A DIVERTICULAR DISEASE, UNDERWENT A CLOSURE OF COLOSTOMY FOLLOWING HARTMAN PROCEDURE (DONE ON (B)(6) 2011). THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. ACCORDING TO THE REPORT, ON POD 7, THE PT WAS RE-OPERATED AND A TOTAL DEHISCENCE OF THE ANASTOMOSIS WAS FOUND (WITHOUT ANY EVIDENCE FOR THE COLONRING AT THE TIME OF THE RE-OPERATION).

    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) 43271238

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention ORAL DIABETIC MEDICATION