BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2097754 · Received April 12, 2011

    Report

    Report Number
    3005278776-2011-00026
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 12, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 PURSUANT TO THE PRODUCT SPECIFICATIONS. ANASTOMOTIC LEAKAGE IS AN ANTICIPATED COMPLICATION OF COLORECTAL ANASTOMOTIC PROCEDURES AND THE CURRENT CUMULATIVE LEAK RATE FOUND WITH THE USE OF THE COLONRING DEVICE IS WITHIN THE RANGE REPORTED IN THE LITERATURE FOR ANASTOMOSIS DEVICES. IT WAS REPORTED BY NITI REPRESENTATIVE WHO ATTENDED THE SURGERY THAT IT WAS VERY LIKELY THAT THE LEAK WAS FROM THE ANTERIOR PORTION WHICH WAS LEAKING INTRA-OPERATIVELY AND TO WHICH SUTURES WERE APPLIED. ADDITIONALLY, AGAINST THE ROUTINE PROTOCOL, THE DISTAL DONUT WAS NOT INSPECTED FOR COMPLETENESS DUE TO THE LARGE AMOUNT OF STOOL. IT WAS NOT POSSIBLE TO CONFIRM THE DISTAL DONUT AND IT APPEARED TO NOT BE INTACT. IT IS THEREFORE VERY LIKELY THAT THIS EVENT IS RELATED TO THE PROCEDURE AND NOT TO THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LAPAROSCOPIC SIGMOID RESECTION FOR DIVERTICULAR DISEASE. THE ANASTOMOSIS WAS CREATED WITH THE COLONRING DEVICE. ON POD 4, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. SMALL BOWEL OBSTRUCTION WAS INDICATED ON CT. ON POD 5 A GASTROGRAFIN ENEMA INDICATED AN ANASTOMOTIC LEAK. THE ANASTOMOSIS WAS TAKEN DOWN AND AN HARTMAN PROCEDURE WAS 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 43001007

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention TRICOR| CRESTOR