BEUDAMED
    FDA Adverse Event Other Summary report: N

    EC-250HL5

    MDR report key: 964104 · Received June 14, 2006

    Report

    Report Number
    2431293-2006-00003
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    April 11, 2006
    Report Date
    June 7, 2006
    Manufacturer
    FUJINON INC.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS INCIDENT CONCLUDED THIS WAS THE RESULT OF THE USER NOT PROPERLY INSTALLING THE TUBING AND/OR ADAPTER. THIS ALLOW FECAL MATTER AND WATER TO BACK UP FROM THE ENDOSCOPE INTO THE TUBING. THIS IS AN ISOLATED INCIDENT (ONLY REPORT OF THIS NATURE). THIS INCIDENT DID NOT CAUSE AN ADVERSE EVENT NOR DO WE BELIEVE THIS IS LIKELY TO CAUSE AN ADVERSE EVENT. THE CUSTOMER WAS RETRAINED ON HOW TO USE THE ADAPTERS.

    Description of Event or Problem · 1

    RECEIVED A USER REPORT FROM HOSP. THE REPORT STATED THAT DURING A COLONOSCOPY PROCEDURE A YELLOW FLUID REFLUXED THROUGH THE FLUSHING CHANNEL OF THE COLONOSCOPE INTO THE TUBING THAT ATTACHES TO THE WATER BOTTLE. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EC-250HL5 COLONOSCOPE FDF FUJINON INC. EC-250HL5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other