BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1970256 · Received January 14, 2011

    Report

    Report Number
    3005278776-2010-00163
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 22, 2010
    Report Date
    December 17, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; (B)(4)) 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 EVALUATION, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. ANASTOMOTIC LEAKAGE, INCLUDING ABSCESS, 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

    A PATIENT UNDERWENT LAPAROSCOPIC LOW ANTERIOR RESECTION DUE TO A COLON MALIGNANCY USING THE COLONRING DEVICE. ON (B)(6) 2010 (APPROXIMATELY 2 MONTHS PO), THE PATIENT VISITED THE CLINIC AND COMPLAINED OF DEFECATION DIFFICULTIES. DIGITAL RECTAL EXAM SHOWED WEB AROUND ANASTOMOTIC SITE. THE SURGEON PERFORMED FINGER DILATATION. AT THE NIGHT, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND VISITED ER. AN ABDOMINO-PELVIC CT SCAN WAS PERFORMED DETECTING ABSCESS AT THE PELVIC CAVITY DUE TO ANASTOMOSIS SITE LEAKAGE. AN EMERGENCY OPERATION WAS PERFORMED WITH IRRIGATION AND DRAINAGE. FOLLOWING THE OPERATION THE SYMPTOMS WERE RESOLVED.

    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 43271210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention LIPITOR| ACTONEL| ASPIRIN 81MG| NIACIN| METFORMIN| PROTONIX