BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING CAR 27/COLONRING

    MDR report key: 1800942 · Received August 10, 2010

    Report

    Report Number
    3005278776-2010-00120
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 14, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 AND EVALUATED. NO FAILURE WAS DETECTED AND THE RING WAS FOUND TO BE WITHIN ITS SPECIFICATION. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS OF 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.

    Description of Event or Problem · 1

    A PATIENT SUFFERING FROM RECTAL CANCER AND CROHN'S DISEASE UNDERWENT LEFT HEMICOLECTOMY PROCEDURE. SIDE TO END ANASTOMOSIS WAS CREATED WITH THE CAR DEVICE. THE ANASTOMOSIS BROKE DOWN AFTER 5 DAYS. HARTMANN WITH PROTECTIVE COLOSTOMY WAS PERFORMED.

    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 43271134T

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention