BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1897443 · Received November 3, 2010

    Report

    Report Number
    3005278776-2010-00144
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 4, 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

    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 PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE DEVICE WAS RETURNED AND EVALUATED. NO FAILURE WAS DETECTED AND THE RING WAS FOUND TO BE WITHIN ITS SPECIFICATIONS. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES WITH THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE COLON RING DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. THE PATIENT PRESENTED WITH SIGNIFICANT UNDERWEIGHT (B)(6). PATIENT'S CO-MORBIDITIES INCLUDING HEAVY NICOTINE AND ALCOHOL ABUSE, AS WELL AS HIS IMPAIRED NUTRITIONAL STATUS PRIOR TO THE COLORECTAL SURGERY (I.E. LOW ALBUMIN) ARE KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK OF ANASTOMOTIC FAILURE.

    Description of Event or Problem · 1

    A LEAK WAS REPORTED IN A PT WHO UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, DUE TO DIVERTICULITIS: "PATIENT STARTED TO SUFFER FROM ABDOMINAL PAINS ON OCTOBER 3RD. HE ARRIVED TO THE HOSPITAL ON OCTOBER 4TH. HE HAD: SWOLLEN ABDOMEN, VOMITING, CREPITUS RIGHT SIDE. ON OCTOBER 5TH, A CT SCAN DEMONSTRATED A PROBABLE PERFORATION ON THE CRANIAL SIDE OF THE ANASTOMOSIS. ON OCTOBER 5TH, A TAKE DOWN OF THE ANASTOMOSIS AS WELL AS A HARTMANN PROCEDURE WERE PERFORMED."

    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) 43001006

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention AMOXICILLINE| CALVULAANZUUR