BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2010440 · Received March 1, 2011

    Report

    Report Number
    3005278776-2011-00006
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 1, 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 COMPRESSION ELEMENT OF THE DEVICE (RING) WAS RETURNED AND EVALUATED BY THE MFR. THE METAL RING WAS FOUND TO BE INTACT, WHILE, THE PLASTIC ANVIL RING WAS RECEIVED IN A DEFORMED CONDITION, PROBABLY DUE TO EXPOSURE TO HEAT FOLLOWING, ITS EXTRACTION, MAKING ITS MECHANICAL TESTING IMPOSSIBLE. THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THIS PT SUFFERED FROM VARIOUS SERIOUS, CO-MORBIDITIES INCLUDING OBESITY AND COPD, RECEIVING STEROIDS, AND THEREFORE AT INCREASED RISK OF LEAKAGE FOLLOWING ANASTOMOSIS. YET, THE CURRENT CUMULATIVE LEAK AND MORTALITY 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

    PT SUFFERING OF RECTAL MALIGNANCY UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION. THE ANASTOMOSIS WAS CREATED USING THE COLONRING DEVICE. ON POD 2, LARGE LEAKAGE WITH SEVERE PERITONITIS REVEALED TO URGENT SURGICAL REVISION AND HARTMAN OPERATION. DURING THE RE-OPERATION, IT WAS DETECTED THAT THE LEAKAGE WAS IN THE CROSSING AREA OF RING AND STAPLER LINE AT THE OUTSIDE OF THE RING. THE PT DIED ON (B)(6) 2011 DUE TO SEPTIC SHOCK WITH SEVERE ORGAN FAILURE.

    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 43271222T

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death CARVERDILOL| BUDIAIR| THEOPHYLLINE| SIMVASTATIN| PANTOPRAZOLE