BEUDAMED
    FDA Adverse Event Injury Summary report: N

    83 PLUS

    MDR report key: 778846 · Received October 4, 2006

    Report

    Report Number
    778846
    Event Type
    Injury
    Date Received
    October 4, 2006
    Date of Event
    September 25, 2006
    Report Date
    October 4, 2006
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD COLONOSCOPY AND RETURNED TO HOSPITAL EMERGENCY DEPARTMENT THREE DAYS LATER WITH A NEW REPORT OF PAIN, DIARRHEA, AND BRIGHT RED BLOOD PER RECTUM SINCE THE ORIGINAL COLONOSCOPY. SEEN IN EMERGENCY DEPARTMENT AND FOLLOW UP WITH A FLEXIBLE SIGMOIDOSCOPY AND BIOPSY DONE WITH RESULT OF ACUTE COLITIS, POSITIVE FOR CHEMICAL INDUCED PROBABLY DUE TO GLUTARALDEHYDE EXPOSURE. PATIENT ADMITTED TO HOSPITAL.DISINFECTANT HOSING TO ENDOSCOPE WAS FOUND TO BE CRACKED AND SPLIT. APPEARS HOSING WAS RUBBING AGAINST THE METAL FITTING. NEW ADDITIONAL TUBING INSPECTION WAS ADDED TO THE DISINFECTION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 83 PLUS WASHER, DISINFECTOR FEB CUSTOM ULTRASONICS INC. 83 PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R