Events

Recall of Olympus TJF-Q180V Duodenovideoscope

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Olympus Medical Systems Corporation.

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
    19704
  • Event Initiated Date
    2016-02-01
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Olympus (NZ) Ltd, 15D Paul Matthews Road, Albany, Auckland
  • Reason
    Nature of correction.:, there will be:, 1. minor changes to parts around the forceps elevator to improve the tolerance, 2. minor changes to the reprocessing manual (the forceps elevator must be raised and lowered during the leakage testing and updated warnings for aer and reprocessing workflow), 3. changes to the operation manual (each tjf-q180v will be required to be returned to olympus for an annual inspection of the forceps elevator surrounding parts).
  • Action
    Instructions for use to be updated

Device

Olympus TJF-Q180V Duodenovideoscope

Manufacturer

Olympus Medical Systems Corporation