Events

Recall of Device Recall Ureteroreno videoscope URFV2 and URFV2R

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
    75993
  • Event Risk Class
    Class 2
  • Event Number
    Z-1252-2017
  • Event Initiated Date
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151898
  • 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
    Endoscope, accessories, narrow band spectrum - Product Code NWB
  • Reason
    Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
  • Action
    The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking 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 and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.

Device

Device Recall Ureteroreno videoscope URFV2 and URFV2R
  • Model / Serial
    All serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution-US Nationwide and country of: Canada.
  • Product Description
    Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories || The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
  • 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