BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC 200LT

    MDR report key: 273543 · Received April 12, 2000

    Report

    Report Number
    MW1018655
    Event Type
    Malfunction
    Date Received
    April 12, 2000
    Date of Event
    March 29, 2000
    Manufacturer
    FUJINON INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COLONOSCOPE BIOPSY CHANNEL BECAME OBSTRUCTED MIDWAY THROUGH PROCEDURE, PREVENTING OPERATING PHYSICIAN FROM PERFORMING SUBSEQUENT POLYPECTOMIES AFTER THE INITIAL POLYPECTOMY WAS DONE. ALSO UNABLE TO PASS A SCLEROTHERAPY NEEDLE TO TATTOO A SMALL LESION FOR LATER EXAM BECAUSE OF OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EC 200LT ENDOSCOPE KOG FUJINON INC. EC200LT *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other