BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1962834 · Received January 13, 2011

    Report

    Report Number
    3005278776-2010-00162
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NITI SURGICAL SOLUTIONS LTD; 3005278776) AND (B)(4), AS NITI SURGICAL SOLUTIONS LTD SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE PRODUCTION HISTORY FILES WERE REVIEWED AND FOUND TO BE IN ORDER, INDICATING THAT THE DEVICE WAS RELEASED PURSUANT TO THE PRODUCT SPECIFICATIONS. THE DEVICE WAS RETURNED AND EVALUATED BY THE MANUFACTURER. NO FAILURE WAS DETECTED AND THE DEVICE WAS FOUND TO BE WITHIN ITS SPECIFICATION. SINCE THE DEVICE RETURNED FOR INVESTIGATION AFTER MANIPULATIONS AT THE SITE, THE ALLEGED FAILURE COULD NOT BE FURTHER INVESTIGATED AND NO FURTHER CONCLUSIONS COULD BE DRAWN. THE ALLEGED FAILURE IS MOST PROBABLY RELATED TO ITS OPERATION, AS NO DEVICE FAILURE WAS FOUND, THE DOUGHNUTS WERE FOUND TO BE INTACT AND DURING ITS INVESTIGATION, THE DEVICE FULLY FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    A PT UNDERWENT LAPAROSCOPIC SIGMOIDECTOMY DUE TO A DIVERTICULAR DISEASE. THE ANASTOMOSIS WAS CREATED WITH THE COLONRING DEVICE. DURING THE PROCEDURE, WHEN FIRING THE DEVICE ACCORDING TO DEVICE INSTRUCTIONS, NO PROGRAMS WERE ENCOUNTERED. SUBSEQUENTLY, WHEN THE DEVICE WAS REMOVED FROM THE PT, THE ANASTOMOSIS COMPLETELY FELL APART. THE ANASTOMOSIS WAS RE-DONE WITH A STAPLER.

    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 43001005

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ASPIRIN 81MG| LIPITOR| PROTONIX| NIACIN| METFORMIN| ACTONEL