BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2191115 · Received July 29, 2011

    Report

    Report Number
    3005278776-2011-00036
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 7, 2010
    Report Date
    June 29, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS LTD; 3005278776) 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 COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES WITH NO RELATION TO THE METHOD USED FOR THE CREATION OF THE ANASTOMOSIS. RECTOSCOPIC EXAMS DURING THE FIRST MONTH FOLLOWING THE PROCEDURE, LOW ALBUMIN VALUES AND CHEMORADIATED TISSUE ARE CONSIDERED AS RISK FACTOR FOR POSTOPERATIVE LEAKAGE. THE CURRENT CUMULATIVE LEAK RATE ASSOCIATED WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR OTHER METHODS. AN INDEPENDENT QUALITY AND SAFETY MONITORING COMMITTEE HAS FOUND THE RELATION OF THE EVENT TO THE DEVICE TO BE UNDETERMINED.

    Description of Event or Problem · 1

    THE PT HAD AN OPEN LAR PROCEDURE FOR MALIGNANT RECTAL TUMOR. THE ANASTOMOSIS WAS CREATED WITH THE COLONRING DEVICE AND ILEOSTOMY WAS CONSTRUCTED. APPENDECTOMY PROCEDURE WAS ALSO PERFORMED WITHIN THE SAME OPERATION. RECTOSCOPIC EXAM BEFORE DISCHARGE REVEALED THAT THE RING IS SLIGHTLY DISLOCATED AND A SMALL INSUFFICIENCY. A DAY AFTER DISCHARGE THE PT RETURNED TO THE HOSPITAL WITH FEVER, WORSENING OF GENERAL CONDITION AND A HIGH OUTPUT STOMA. RECTOSCOPIC EXAM REVEALED THAT THE RING WAS COMPLETELY DISLOCATED AND LOT OF PUS. AFTER 5 RECTOSCOPIC EXAMS, THE DIAGNOSIS WAS ANASTOMOTIC INSUFFICIENCY AND AN ABSCESS. THE PT WAS TREATED WITH LAVAGE. THE RING WAS REMOVED ON (B)(6).

    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) 43001001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention METAMIZOL| PANTOZOL