BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1947715 · Received December 30, 2010

    Report

    Report Number
    3005278776-2010-00160
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 30, 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 DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE PT SUFFERED FROM MULTIPLE MEDICAL CONDITIONS, ADVANCED AGE AS WELL AS A POST OPERATIVE ASPIRATION WHICH LED TO BILATERAL PNEUMONIA RESULTING IN MULTI-ORGAN FAILURE AND DEATH. THE AUTOPSY PERFORMED ON (B)(6) 2010 WAS CORRELATIVE WITH MULTI ORGAN FAILURE. THE ANASTOMOSIS WAS FOUND TO BE INTACT. BOTH THE SURGEON AND AN INDEPENDENT QUALITY AND SAFETY MONITORING COMMITTEE CONCLUDED THAT THE DEATH IS NOT RELATED TO THE COLONRING DEVICE.

    Description of Event or Problem · 1

    OPEN COLORECTAL ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE DUE TO DIVERTICULAR DISEASE. ON POD 6, THE PT EXPERIENCE ASPIRATION AND CONSECUTIVE BILATERAL PNEUMONIA AND RESPIRATORY FAILURE. ON POD 7, THE PT HAD MULTI ORGAN FAILURE THAT LATER RESULTED IN DEATH. AUTOPSY WAS PERFORMED ON (B)(6) 2010 WITH NO EVIDENCE OF ANASTOMOTIC LEAKAGE OR DEVICE RELATED PROBLEM.

    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 83 YR Death BEZAFIBRAT| PANTOPRAZOL| ESCITALOPRAM| DONEPEZIL