BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2010586 · Received March 1, 2011

    Report

    Report Number
    3005278776-2011-00007
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 (NITI SURGICAL SOLUTIONS INC.; (B)(4)), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE COMPRESSION ELEMENT OF THE DEVICE (RING) WAS RETURNED AND EVALUATED BY THE MANUFACTURER. NO FAILURE WAS DETECTED AND THE RING WAS FOUND TO BE WITHIN ITS SPECIFICATIONS. THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE PT UNDERWENT A SIGMOIDOSTOMY THAT WAS COMPLICATED WITH AN EVENT OF BLEEDING NECESSITATING THE ADDITION OF SUTURES OVER THE ANASTOMOSIS WHICH WAS LATER FOUND TOTALLY OPEN. 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.

    Description of Event or Problem · 1

    PT SUFFERING OF DIVERTICULAR DISEASE UNDERWENT OPEN SIGMOIDECTOMY. THE ANASTOMOSIS WAS CREATED USING THE COLONRING DEVICE. DURING THE PROCEDURE SMALL ANASTOMOSIS BLEEDING WAS DETECTED WHICH WAS RESOLVED BY ADDITION OF SUTURES OVER THE ANASTOMOSIS. ON POD 5, PAIN OCCURS AFTER SECOND DEFECATION. ONE HOUR LATER, RE-OPERATION WAS CONDUCTED AND THE ANASTOMOSIS WAS FOUND TOTALLY OPEN. THE COLONRING WAS CLOSED AND HANGING AT ONE SMALL POINT IN THE PROXIMAL SIDE. RE-LAPAROTOMY WITH STOMA AND BLIND OBSTRUCTION OF THE RECTUM WAS CONDUCTED.

    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 432712225

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention