Events

Field Safety Notices about OLYMPUS urethro-reno endoscopes

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Olympus.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Olympus has learned of a problem that requires your attention. this urgent safety notice applies to ulyfus urf-v2 and urf-v2r uretero-reno videos, urf-p6 uretero-reno fiber scopes and urf-p6r, and our records indicate that your establishment has purchased one or more of these products. urf-v2, urf-v2r and urf-p6, urf-p6r endoscopes are intended for use in endoscopic diagnoses and treatment within the ureter and kidney. the urf-p6 and p6r endoscopes are also intended for use in endoscopic diagnoses and treatment within the biliary tract (bile duct and hepatic duct).   olympus initiated this remedial action after investigating five adverse events with respect to the urf-v2 and urf-v2r endoscopes when fracture of the endoscope introductory tube fracture occurred during the surgical procedure. to date, these adverse events have included two cases of tissue damage, one case of perforation and two cases where the introductory tubes remained within the patient and had to be surgically removed. olympus is writing to inform you of this matter and to recommend specific actions.   olympus has received complaints regarding urf-p6, urf-p6r endoscopes related to deployment tube fractures - none of these cases have resulted in adverse consequences.

Device

OLYMPUS urethro-reno endoscopes
  • Model / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus