Events

Recall of Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and i10/K10 series )

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2013-RN-00909-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00909-1
  • 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 manufacturer has been informed about a product issue involving the of-b194 gas/water feeding valve. the reported defect may prevent stoppage of the supply of co2 gas during an endoscopic procedure with the potential for serious hazard to the patient, including bowel perforation.
  • Action
    Device Technologies is advising customers to stop use of the PTX-OF-B194 Gas/Water Feeding Valve. Device Technologies will arrange for the affected stock to be collected. New stock of PTX-OF-B194 will be available by the end of September 2013. In the interim, customers are asked to use the alternative OF-B188 valve provided.

Device

Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and ...

Manufacturer

Device Technologies Australia Pty Ltd