BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1943859 · Received December 23, 2010

    Report

    Report Number
    3005278776-2010-00156
    Event Type
    Other
    Date Received
    December 23, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. ANASTOMOTIC BLEEDING, ALTHOUGH RARE, YET CONSIDERED AS AN EXPECTED EVENT.

    Description of Event or Problem · 1

    ON POD 7 (B)(6) 2010 IN THE EVENING THE PT REPORTED LITTLE BLEEDING TRANS-ANALLY. ON (B)(6) 2010, FLEXIBLE RECTOSCOPY WAS PERFORMED SHOWING NO ACTIVE BLEEDING BUT CLOTS AT A HEMI-CIRCUMFERENCE OF THE ANASTOMOSIS. RED BLOOD CELL COUNT WAS STABLE. THE SURGEON ASSUMED THAT THE RING WAS MOBILIZED ON THE (B)(6) (PT DID NOT RECOGNIZE PASSAGE AT ALL) AND LED TO MINIMAL BLEEDING. NO INTERVENTION WAS NECESSARY.

    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 43001001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention E. COLI NISSLE| VALSARTAN| LORAZEPAM| MEBEVERINE HYDROCHLORIDE