BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOTIC RING (CAR27)

    MDR report key: 2982347 · Received February 25, 2013

    Report

    Report Number
    3005278776-2013-00001
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 23, 2013
    Manufacturer
    NOVOGI LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NOVOGI LTD.) AND THE IMPORTER ((B)(4)), AS NOVOGI LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE DEVICE OR THE EVENT IS CURRENTLY AVAILABLE. SEVERAL ATTEMPTS TO CONTACT THE SURGEON IN ORDER TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED OR ANY CONCLUSION COULD BE DRAWN. ANASTOMOTIC LEAKAGE IS ONE OF THE MOST COMMON ANTICIPATED COMPLICATIONS OF COLORECTAL SURGERIES AND THE CURRENT LEAK/COMPLICATION RATE FOUND WITH THE UES OF THE COLORING DEVICE IS WITHIN THE LOW RANGE REPORTED IN THE LITERATURE FOR ANASTOMOTIC DEVICES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN END TO SIDE LAPAROSCOPIC SIGMOIDECTOMY DUE TO DIVERTICULAR DISEASE ON (B)(6) 2012. THE PROCEDURE LASTED 120 MINUTES WITH NO COMPLICATION. ON (B)(6), THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH FEVER AND PAIN. CT SCAN SHOWED AN ANASTOMOTIC LEAKAGE AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM A COMPLETE ANASTOMOTIC BREAKDOWN WAS FOUND AND A LAPAROSCOPIC HARTMAN WAS DONE. ACCORDING TO THE REPORT, THE PATIENT DID WELL AND HAD AN UNEVENTFUL LAPAROSCOPIC COLOSTOMY CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79012 COLONRING/COMPRESSION ANASTOMOTIC RING (CAR27) IMPLANTABLE CLIP (FZP) FZP NOVOGI LTD. COLONRING (CAR27)

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R KARIVA| CLARITIN| XANAX