Events

Recall of Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Corporation of the Americas.

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
    73640
  • Event Risk Class
    Class 2
  • Event Number
    Z-1845-2016
  • Event Initiated Date
    2016-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144647
  • 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
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Reason
    New reprocessing instructions for the olympus tjf-160/vf duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (maj-1534), which is enclosed with the notification.
  • Action
    Olympus notified customers on 03/14/2016 via an Urgent Safety Notification letter that referenced discontinuation of previously distributed copies of the TJF-160F/VF Reprocessing Manual. Customers were asked to inspect their inventory and discard any existing inventory of TJF-160F/VF Reprocessing Manuals. They were asked to update their information with the enclosed TJF-160F/VF Reprocessing Manual, which contains new brushing and flushing steps for the TJF-160F/VF elevator mechanisms and the forceps elevator recesses. Instuctions for cleaning and a new cleaning brush (used for cleaning the device) was included with the notification. Customers were asked to ensure all reprocessing personnel are completely knowledgeable and throughly training on the new reprocessing instructions in the new Reprocessing Manual.

Device

Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF
  • Model / Serial
    Models: TJF-160F and TJF-160VF, all serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide:
  • Product Description
    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF || used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Manufacturer Address
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA