BEUDAMED
    FDA Adverse Event Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1652309 · Received March 31, 2010

    Report

    Report Number
    3005278776-2010-00067
    Date Received
    March 31, 2010
    Date of Event
    August 5, 2009
    Report Date
    August 9, 2009
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECS. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER CONCLUSIONS COULD BE DRAWN BASED ON THE AVAILABLE INFO. SUCH MALFUNCTION IS DETECTABLE AND CAN BE RESOLVED INTRAOPERATIVELY WITHOUT FURTHER DEVICE RELATED SAFETY CONCERNS.

    Description of Event or Problem · 1

    THE PT SUFFERING FROM ULCERATIVE COLITIS UNDERWENT OPEN ILEOANAL PROCEDURE WITH ILEO-POUCH. DURING THE ANASTOMOSIS PROCEDURE WITH THE CAR DEVICE, THE ANVIL WAS NOT SEATED PROPERLY ON THE DEVICE WHEN FIRED. A SECOND DEVICE WAS USED AND THE PROCEDURE PASSED SUCCESSFULLY.

    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 43271151

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization