BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 2850033 · Received November 26, 2012

    Report

    Report Number
    3005278776-2012-00010
    Event Type
    Injury
    Date Received
    November 26, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    NOVOGI LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MANUFACTURER (NOVOGI LTD; (B)(4)) AND THE IMPORTER ((B)(4)), AS NOVOGI LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. REVIEW OF THE DEVICE'S PRODUCTION HISTORY FILES INDICATED THAT THE DEVICE WAS RELEASED PURSUANT TO ITS SPECIFICATIONS. THE RING WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION REVEALED FEW OBSERVATIONS, SUCH AS A SLIGHT MISALIGNMENT BETWEEN THE METAL RING AND A SINGLE STAPLE WITHIN THE RING, WHICH ARE EXPECTED AS PART OF THE INTENDED MODE OF OPERATION OF THE DEVICE AND ARE COMMONLY SEEN IN RINGS EXCRETED FOLLOWING SUCCESSFUL PROCEDURES. MECHANICAL AND FUNCTIONAL TESTS OF THE RING REVEALED NO FAILURE AND THE RING WAS FOUND TO BE WITHIN ITS SPECIFICATIONS. IN CASE THAT ADDITIONAL INFORMATION WOULD BE AVAILABLE FOLLOWING THE COMPLETION OF THE RING INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. IT SHOULD BE NOTED THAT IN GENERAL, POSITIVE BUBBLE TEST MAY BE RELATED TO THE SURGICAL TECHNIQUE, THE PATIENT'S TISSUE CONDITION AND/OR THE DEVICE USED. LEAKS DETECTED AT THIS STAGE, AS PART OF THE SURGICAL PROCEDURE ENABLE IMMEDIATE INTRAOPERATIVE REPAIR AND THEREFORE ARE GENERALLY NOT ASSOCIATED WITH FURTHER SAFETY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS OPERATED FOR OBSTRUCTION AND LIVER RESECTION (NODES REMOVAL). ACCORDING TO THE REPORT, FOLLOWING THE LOW ANTERIOR RESECTION PROCEDURE AND CREATION THE ANASTOMOSIS WITH THE COLONRING DEVICE, UPON BUBBLE TEST, THE SURGEON NOTED BUBBLES COMING OUT AND THE COLON SLIPPED OUT FROM THE ANASTOMOSIS RING RESULTING IN LARGER GAP DEVELOPMENT OF THE ANASTOMOSIS. INSPECTION OF THE DONUTS SHOWED BOTH THE PROXIMAL AND DISTAL INTACT AND PERFECT CUT. THE CLINICAL OPINION OF THE SURGEON WAS THAT THE ANASTOMOSIS WAS NOT SALVAGEABLE AND HE ORDERED FOR REWORK OF THE ANASTOMOSIS. NEW ANASTOMOSIS WAS CREATED WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27) IMPLANTABLE CLIP (FZP) FZP NOVOGI LTD. COLONRING (CAR27) 43271253

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention