Events

Recall of Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V

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
    73059
  • Event Risk Class
    Class 2
  • Event Number
    Z-0757-2016
  • Event Initiated Date
    2016-01-08
  • Event Date Posted
    2016-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142937
  • 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
    Olympus america inc is conducting a voluntary removal/corrective action of all tjf-q180v duodenoscopes in order to replace the forceps elevator mechanism olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared tjf-q180v 510k.
  • Action
    Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.

Device

Device Recall Evis Exera II Duodenovideoscope Olympus TJFQ180V
  • Model / Serial
    all codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution except PR
  • Product Description
    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope || Product Usage: || This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy 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