BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2130580 · Received June 14, 2011

    Report

    Report Number
    3005278776-2011-00032
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 14, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (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 PURSUANT TO THE PRODUCT SPECIFICATIONS. ANASTOMOTIC LEAKAGE IS AN ANTICIPATED COMPLICATION OF THE COLORECTAL ANASTOMOTIC PROCEDURES AND THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. IT SHOULD BE NOTED THAT, IN THIS CASE, THE FACT THAT THE DONUTS WERE FOUND INCOMPLETE AND NO LEAK TEST WAS PERFORMED, CANNOT RULE OUT AN ISSUE RELATED TO THE SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN OPEN RESECTION PROCEDURE FOR RECTAL CANCER. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING/CAR DEVICE. THE FOLLOWING WAS REPORTED: "THE CAR WAS FIRED SUCCESSFULLY. DISTAL DONUT WAS NOT COMPLETE. RECTAL TUBE WAS PUT INSIDE. DID NOT DO LEAKAGE TEST BY AIR. ON POD2, THE PT DEVELOPED FEVER AND DIARRHEA. ON POD 7, LEAKAGE WAS DIAGNOSED. HARTMAN PROCEDURE WAS PERFORMED ON THE SAME DAY."

    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) 43271212

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention