Events

Recall of Device Recall URFP6 Ureteroreno fiberscope and URFP6R Ureteroreno fiberscope

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
    75990
  • Event Risk Class
    Class 2
  • Event Number
    Z-1251-2017
  • Event Initiated Date
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151891
  • 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
    Choledochoscope and accessories, flexible/rigid - Product Code FBN
  • Reason
    Olympus is recalling the urf-p6/p6r endoscopes due to a similar device (urf-v2/v2r endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. in an effort to mitigate a potential risk to patient health, olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
  • Action
    Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.

Device

Device Recall URFP6 Ureteroreno fiberscope and URFP6R Ureteroreno fiberscope

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