BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1760715 · Received July 15, 2010

    Report

    Report Number
    3005278776-2010-00103
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND THE (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE DETAILS (SN/LOT) WERE NOT AVAILABLE, THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO CONCLUSION COULD BE DRAWN BASED ON THE LIMITED INFORMATION THAT IS AVAILABLE. LEAKS ARE ANTICIPATED ADVERSE EVENTS IN COLORECTAL ANASTOMOTIC PROCEDURES, AND 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

    IN 4TH DAY POST OP, A 360 DEGREE OPENING OF BOWEL AROUND THE LINE OF THE COLON RING WAS INDICATED. THE RING WAS PERFECTLY CLOSED. THE PATIENT HAS BEEN RE-OPERATED WITH A COLOSTOMY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention