BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 2115170 · Received May 31, 2011

    Report

    Report Number
    3005278776-2011-00030
    Event Type
    Injury
    Date Received
    May 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    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 (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 EVAL, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECS. STRICTURES ARE COMMON COMPLICATIONS OF COLORECTAL ANASTOMOTIC PROCEDURES AND MAY BE RELATED TO THE SURGICAL PROCEDURE RATHER THAN TO THE DEVICE. IN THIS CASE, IT WAS REPORTED THAT NO COMPLICATIONS WITH THE DEVICE OCCURRED.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE FOR COLONIC CANCER. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE. A STRICTURE WAS REPORTED A FEW MONTHS LATER. NO COMPLICATIONS WITH THE COLONRING DEVICE WERE NOTED.

    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 43271211

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention METRONIDAZOLE