BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING

    MDR report key: 1800939 · Received August 10, 2010

    Report

    Report Number
    3005278776-2010-00118
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 12, 2010
    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; 3005278776) AND THE (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE PRODUCTION HISTORY FILE WAS REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE RING WAS RETURNED FOR EVALUATION AND IS STILL BEING EVALUATED. NO CONCLUSIONS COULD BE CURRENTLY DRAWN OUT BASED ON THE AVAILABLE INFORMATION. LEAKS ARE ANTICIPATED ADVERSE EVENTS IN COLORECTAL ANASTOMOTIC PROCEDURES AND THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE CAR DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. THE PATIENT WAS SEVERELY OBESE, A FACTOR WHICH IS KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT HAND ASSISTED LAP SIGMOIDECTOMY SURGERY DUE TO DIVERTICULAR DISEASE. A REPAIR OF COLOVESICAL FISTULA WAS PERFORMED DURING THE PROCEDURE. END TO END ANASTOMOSIS WAS PERFORMED WITH THE CAR. UPON HEIGHTENED FEVER AND TENDERNESS ON POD 5, A GASTROGRAFFIN ENEMA-CONTRAST REVEALED LEAK. PATIENT WAS TAKEN BACK TO OPERATING ROOM FOR RE-OPERATION. OPEN EXPLORATION REVEALED LEAK PROXIMALLY AND ANTERIORLY WITH RING IN PLACE IN RECTUM. RECTAL STUMP WAS CLOSED OVERSEWN, AND PROXIMAL WAS PULLED UP TO AN END-COLOSTOMY. TEAR WAS PROXIMAL - ANTERIOR, RECTUM WAS THICKENED, TWO LAYERS OF RECTAL TISSUE SEEN ON REOP. PLAN TO LEAVE IN PLACE FOR AT LEAST 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27/COLONRING 43271208

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention