BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2193685 · Received August 1, 2011

    Report

    Report Number
    3005278776-2011-00038
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    June 15, 2010
    Report Date
    July 6, 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; (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 IS ONE OF THE MOST COMMON COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES WITH NO RELATION TO THE METHOD USED FOR THE CREATION OF THE ANASTOMOSIS. THE CURRENT CUMULATIVE LEAK RATE ASSOCIATED WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR OTHER METHODS. INDEPENDENT QUALITY AND SAFETY MONITORING COMMITTEE FOUND THE RELATION OF THE EVENT TO THE DEVICE TO BE UNDETERMINED BUT POTENTIALLY TECHNIQUE RELATED.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN OPEN LOW ANTERIOR RESECTION DUE TO RECTAL TUMOR. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. APPENDECTOMY PROCEDURE WAS ALSO PERFORMED WITHIN THE SAME OPERATION. THE PT CAME TO CONSULTATION AT THE EMERGENCY DEPT ON (B)(6), REPORTED ON INCREASING ANAL PAIN. RECTOSCOPY WAS PERFORMED DURING WHICH THE RING WAS FOUND DETACHED AND WAS REMOVED. A SMALL INSUFFICIENCY WAS DIAGNOSED AND THE PT WAS TREATED WITH A LAVAGE.

    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) 43271219

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention BISOLICH| SIMVASTATIN| ENABETA| SPASMEX