BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1884933 · Received October 14, 2010

    Report

    Report Number
    3005278776-2010-00139
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 17, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS, LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 AVAILABLE FOR EVAL, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. NO FURTHER CONCLUSIONS COULD BE DRAWN BASED ON THE AVAILABLE INFO. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL SURGERIES WITH BOTH STAPLERS AND COMPRESSION ANASTOMOSIS DEVICES. 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 LEAK WAS REPORTED IN PT WHO UNDERWENT AN HAND ASSISTED LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, DUE TO RECTAL CANCER WITH ANASTOMOSIS CREATED WITH THE CAR DEVICE: "THE PT WENT HOME ON POD 3, CAME BACK TO ER ON POD 7, X-RAY SHOWED FREE AIR. HE WAS TOOK TO OPERATING ROOM, REVEALED A POSTERIOR TEAR. THE PT WAS DIVERTED."

    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 43271215

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention