Events

Recall of Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia Pty Ltd.

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
    RC-2017-RN-01519-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01519-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Omsc has received a small number of adverse event reports globally for the urf-v2 associated with damage to the bending section. to date, no adverse events have been reported to olympus in australia for the urf-v2 and no adverse events reported globally for the urf-p6. further to olympus’ safety alert issued in december 2016 (rc-2016-rn-01653-1), the manufacturer has modified the design of the bending section of the urf-v2 and urf-p6 to address any deficiencies that may have attributed to the adverse events reported globally.
  • Action
    Olympus is advising hospitals to identify affected devices from their inventory. When replacement URF-V2 and URV-P6 devices are available, an Olympus Customer Operations Specialist will contact users to exchange devices at affected facilities. In the interim, users may refer to the IFU and Safety Alert issued by Olympus for the correct inspection and use of the device.

Device

Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope
  • Model / Serial
    Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope Model Numbers: URF-V2 and URF-P6ARTG Numbers: 211118 and 131068
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd