BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1667650 · Received April 23, 2010

    Report

    Report Number
    3005278776-2010-00078
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 24, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NITI SURGICAL SOLUTIONS LTD) AND THE IMPORTER (NITI SURGICAL SOLUTIONS INC), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVAL AND NO FURTHER INFO REGARDING THE DEVICE OR THE PT IS CURRENTLY AVAILABLE. LEAKS ARE ANTICIPATED ADVERSE EVENTS IN COLORECTAL ANASTOMOTIC PROCEDURES. THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE CAR DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES.

    Description of Event or Problem · 1

    A PT HAD AN OPEN LAR PROCEDURE ON (B) (6) 2010. THE ANASTOMOSIS WAS PERFORMED WITH THE CAR DEVICE. A LEAK WAS DETECTED AND THE ILEOSTOMY WAS MAINTAINED.

    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 43271160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention