Events

Safety Alert for uretero-reno videoscopes and uretero-reno fiberscopes

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Olympus.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-01-09
  • Event Date Posted
    2017-01-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170109a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: olympus uretero-reno videoscopes and uretero-reno fiberscopes medical device manufacturer, olympus, has issued medical device safety alerts concerning its uretero-reno videoscopes (model numbers: urf-v2 and urf-v2r) and uretero-reno fiberscopes (model numbers: urf-p6 and uf- p6r). for uretero-reno videoscopes, the manufacturer has initiated a corrective action following investigation of customer complaints regarding the breakage of the urf-v2/v2r insertion tube bending section during surgical procedures. to date, some of these complaints are associated with tissue trauma (including one complaint of perforation, and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed). for uretero-reno fiberscopes, the manufacturer has received complaints on the urf-p6/p6r insertion tube, and breaks of the bending tube, but these complaints have not resulted in any known adverse events. the manufacturer is aware of adverse event complaints on the urf-v2/v2r endoscopes which have a similar structure to the urfp6/p6r endoscopes. the manufacturer advises customers to inspect their inventory for the referenced devices and follow the recommended inspection procedures listed in the “instruction for safe use”. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 january 2017.

Device

uretero-reno videoscopes and uretero-reno fiberscopes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Olympus Uretero-reno Videoscopes and Uretero-reno Fiberscopes
  • Manufacturer
    Olympus

Manufacturer

Olympus