Events

Recall of URETERO-RENO FIBERSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA INC..

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
    71582
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The manufacturer olympus medical systems corp (omsc) has initiated this corrective action following complaints on the urf-p6/p6r insertion tube and breaks of the bending tube. these complaints have not resulted in any known adverse event. the urf-p6/p6r endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter kidney and biliary tract (common bile duct and hepatic duct). omsc is aware of adverse events on the urf-v2/v2r endoscopes which have a similar structure to the urf-p6/p6r endoscopes. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.

Device

URETERO-RENO FIBERSCOPE
  • Model / Serial
    Model Catalog: URF-P6 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: URF-P6R (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    URETERO-RENO FIBERSCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.