BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANDCAC

    MDR report key: 683847 · Received February 21, 2006

    Report

    Report Number
    87602-2006-00001
    Event Type
    Death
    Date Received
    February 21, 2006
    Date of Event
    January 18, 2006
    Report Date
    February 2, 2006
    Manufacturer
    NITI MEDICAL TECHNOLOGIES, LTD.
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT READMITTED IN 06 FOLLOWING ANASTOMOSIS PROCEDURE 10 DAY AGO WITH REPORTED SHORTNESS OF BREATH. THE CONDITION WORSENED 10 DAYS LATER, AND THE REPORTING SURGEN INDICATED THAT HE SUSPECTED AN ANASTOIMOTIC LEAK. DURING REOPERATION THE FOLLOWING DAY, THE SURGEON FOUND A SMALL BOWEL LEAK AT THE SUTURE LINE OF THE ENTEROTOMIES. THE CAC CLIP ANASTOMOSIS WAS INTACT (NO LEAKAGE). PATIENT HAD RESPIRATORY DISTRESS AND MULTIPLE ORGAN FAILURE PASSED 2 DAYS LATER, (SEE ATTACHED DOCUMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDCAC COMPRESSION ANASTOMOSIS CLIP BTI NITI MEDICAL TECHNOLOGIES, LTD. HC30 51301086

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death