BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1880237 · Received October 19, 2010

    Report

    Report Number
    3005278776-2010-00140
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE RING WAS RETURNED AND IS CURRENTLY BEING INVESTIGATED. AN UPDATED REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. 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. THE PATIENT IS SUFFERING FROM MORBID OBESITY, WHICH IS KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE.

    Description of Event or Problem · 1

    ANASTOMOTIC LEAK ON POD 4 WAS REPORTED IN A PATIENT WHO UNDERWENT AN OPEN LAR PROCEDURE DUE TO MALIGNANT RECTAL CANCER WITH THE ANASTOMOSIS CREATED USING THE CAR DEVICE. A STOMA WAS PERFORMED. A STATE OF SHOCK (UNRELATED TO THE DEVICE OR TO THE REPORTED LEAK), WHICH WAS RESOLVED ON THE SAME DAY, WAS REPORTED ON POD 8.

    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 43001002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TAZOCIN 4/G DAY| MEROPENEM 2G/DAY