BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27/COLONRING)

    MDR report key: 1912806 · Received November 4, 2010

    Report

    Report Number
    3005278776-2010-00143
    Event Type
    Other
    Date Received
    November 4, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS, LTD
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 (B)(4), AS NITI SURGICAL SOLUTIONS LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE OUTCOME IS MOST PROBABLY PROCEDURE RATHER THAN DEVICE RELATED, SINCE DURING THE RE-OPERATION, IT WAS FOUND THAT THE ANASTOMOTIC AREA OF THE INITIAL OPERATION IS COMPLETELY INTACT WHILE THE DISTAL PORTION OF THE COLON HAD BECOME ISCHEMIC. IT SHOULD BE NOTED THAT THE PATIENT IS KNOWN TO BE A HEAVY SMOKER WHICH MIGHT CONTRIBUTE AN ADDITIONAL RISK FACTOR TO SUCH ISCHEMIC EVENT. INDEED, THE SURGEON DEFINE THE EVENT AS NON-DEVICE RELATED.

    Description of Event or Problem · 1

    A PATIENT WHO UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE WITH ANASTOMOSIS CREATED WITH THE CAR DEVICE DUE TO LOW RECTAL CANCER, RETURNED ON POD 4 WITH ISCHEMIC DISTAL COLON. RE-OPERATION WAS CONDUCTED AND THE INITIAL ANASTOMOSIS WITH THE DEVICE WAS FOUND TO BE INTACT WITH NO LEAKAGE, NO ABSCESS AND NO PERFORATION. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27/COLONRING) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS, LTD CAR 27/COLONRING 43001005

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention