BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1910581 · Received November 19, 2010

    Report

    Report Number
    3005278776-2010-00149
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 22, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (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 DEVICE WAS NOT RECEIVED FOR EVALUATION AND NO INFO IS AVAILABLE REGARDING ITS SERIAL NUMBER. IN ADDITION, THE AVAILABLE INFO REGARDING THE PT OR THE PROCEDURE IS VERY LIMITED AND THEREFORE, NO FURTHER CONCLUSIONS COULD BE DRAWN. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES WITH BOTH STAPLERS AND COMPRESSION ANASTOMOSIS DEVICES. THE CURRENT CUMULATIVE LEAK RATE FOLLOWING USE OF COLONRING DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES.

    Description of Event or Problem · 1

    ANASTOMOSIS WITH THE COLONRING WAS CREATED IN A PT WHO UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE DUE TO RECTAL MALIGNANCY. A LEAK HAS OCCURRED ON POD 4.

    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 (COLONRING) 43271202

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention