Events

Recall of VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-00695-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00695-1
  • 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
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. in addition, the monitoring of chemical residues was not considered in the reprocessing validation. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidelines. potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. to date, there have been no reports of adverse reactions related to inadequate cleaning, disinfection, sterilisation or chemical residual exposure associated with these devices.(please note that for the endoscopic system, the reprocessing instructions apply to the vueoptic visualisation source as the flexor 180 is intended for one-time use only).
  • Action
    Cook Medical will be updating the reprocessing instructions in the Instructions For Use (IFU). In the interim, users are advised to quarantine any affected products. Use of the affected products can be continued if the updated "Reprocessing Instructions" provided is adhered to. (Users are to note that the reprocessing instructions apply to the VueOptic Visualisation Source as the Flexor 180 is intended for one-time use only).

Device

VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System
  • Model / Serial
    VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic SystemVueOptic Visualisation Source Catalogue Identifier: FVO-150Part Number: G25343Flexor Vue Deflecting Endoscopic System Catalogue Identifiers: FV-090075-150 & FV-090045-150Part Numbers: G50972 & G34306 (respectively)All Lot NumbersARTG Numbers: 211575 and 211572
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd