BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2193654 · Received August 1, 2011

    Report

    Report Number
    3005278776-2011-00037
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 3, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS, LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO ITS SPECS. ANASTOMOTIC LEAKAGE, INCLUDING ABSCESS, IS ONE OF THE MOST COMMON COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES WITH NO RELATION TO THE METHOD USED FOR THE CREATION OF THE ANASTOMOSIS. PT'S CO-MORBIDITIES INCLUDING DIABETES AND OBESITY ARE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE. THE CURRENT CUMULATIVE LEAK RATE ASSOCIATED WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR OTHER METHODS.

    Description of Event or Problem · 1

    THE PT UNDERWENT A COLORECTAL LOW ANTERIOR RESECTION WITH TME DUE TO RECTAL TUMOR. SURGERY APPROACH WAS CONVERTED FROM LAPAROSCOPIC TO OPEN DUE TO EXTENSIVE ADHESIONS FROM PREVIOUS SURGERY. THE ANASTOMOSIS WAS CREATED WITH THE COLONRING DEVICE. CLOSURE OF IATROGENIC SMALL BOWEL ENTEROTOMIES (AWAY FROM THE ANASTOMOSIS) WAS DONE DURING THE SAME PROCEDURE. ABOUT 2 WEEKS POSTOPERATIVELY, THE PT DEVELOPED ABDOMINAL PAIN AND WAS FOUND TO HAVE A SMALL ABSCESS. THE PT UNDERWENT RADIOLOGICAL PERCUTANEOUS DRAINAGE AND WAS PLACED ON PARENTERAL NUTRITION WITH NEAR RESOLUTION OF THE DRAINAGE. SINCE THERE WAS NO OPTION FOR PARENTERAL NUTRITION CARE AT THE LONG-TERM FACILITY, THE PT WAS PLACED ON ELEMENTAL ORAL NUTRITION BUT HAS DEVELOPED 200 - 300 ML DRAINAGE. SCHEDULED TRANSVERSE COLOSTOMY WAS CANCELLED DUE TO PRESENCE OF FEVER, THOUGHT BY THE SURGEON TO BE SECONDARY TO PNEUMONIA.

    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) 43271238

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PROVASTINE| ASA| GLOCOSAMINE CHONDROITIN| LISINOPRIL| METFORMIN 1000 MG B.I.D.