BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1714295 · Received June 6, 2010

    Report

    Report Number
    3005278776-2010-00095
    Event Type
    Injury
    Date Received
    June 6, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 6, 2010
    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; (B) (4)) AND THE IMPORTER ((B) (4)), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE PRODUCTION HISTORY FILES WERE REVIEWED AND INDICATED THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE RING WAS RETURNED AND INVESTIGATED. 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 SURGERIES WITH BOTH STAPLERS AND COMPRESSION ANASTOMOSIS DEVICES AND THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE CAR DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC LEFT HEMICOLECTOMY PROCEDURE DUE TO DIVERTICULITIS IN THE SIGMOID COLON. END TO END ANASTOMOSIS WAS PERFORMED WITH THE CAR. ANASTOMOTIC LEAKAGE WAS INDICATED ON POD 5. LAPAROSCOPIC REVISION WAS PERFORMED, IN WHICH THE ANASTOMOSIS WAS TAKEN DOWN, AND A LAVAGE, CLOSURE OF RECTAL STAMP AND HARTMAN PROCEDURE WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27 43271211

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention