Events

Recall of Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fujinon Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34680
  • Event Risk Class
    Class 2
  • Event Number
    Z-0708-06
  • Event Initiated Date
    2006-03-27
  • Event Date Posted
    2006-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44461
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Colonoscope And Accessories, Flexible/Rigid - Product Code FDF
  • Reason
    Colonoscope insertion tube is not bending properly and is stiff.
  • Action
    Fujinon sent out a Technical Bulletin on 3/27/2006 that instructs the physician to do a bending test with the colonoscope. If the scope does not bend around an 8 inch bending diameter, the scope is not to be used.

Device

Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointesti...
  • Model / Serial
    Catalog Numbers:  EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP.  All lots
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product is distributed nationwide to hospitals and physicians. It was shipped internationally to Canada. US Government accounts include VA medical centers in Spokane WA, St. Louis, MO and Camp Pendleton Naval Hospital in Camp Pendleton, CA.
  • Product Description
    Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
  • Manufacturer
    Fujinon Inc

Manufacturer

Fujinon Inc
  • Manufacturer Address
    Fujinon Inc, 10 Highpoint Dr, Wayne NJ 07470-7431
  • Source
    USFDA