BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2080420 · Received April 22, 2011

    Report

    Report Number
    3005278776-2011-00022
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 RECEIVED FOR EVAL. ALTHOUGH SEVERAL ATTEMPTS WERE MADE, NO INFO COULD BE OBTAINED IN THE CASE REGARDING THE DEVICE IDENTIFICATION (LOT OR SERIAL NUMBER) OR REGARDING THE MEDICAL HISTORY OF THE PT OR THE PROCEDURE. ANASTOMOTIC LEAKAGE IS AN ANTICIPATED COMPLICATION OF 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.

    Description of Event or Problem · 1

    A PT UNDERWENT AN OPEN ANTERIOR RESECTION PROCEDURE DUE TO A COLONIC CANCER. THE PT EXPERIENCED PAIN WHILE STILL IN HOSP AND WAS DIAGNOSED WITH POST OPERATIVE ANASTOMOTIC LEAK. RESOLUTION INCLUDED RE-EXPLORATORY PROCEDURE WITH ILEOSTOMY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention