Events

Recall of HOYA Corporation (PENTAX Medical) – Gas/Water Feeding Valve

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-2014-RN-00711-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00711-1
  • 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
    This action is taken to inform users of a change in the instructions for use related to the proper use of the lubricant oil (ptx-of-z11) applied on the ptx-of-b130 and ptx-of-b194 gas/water feeding valves, as supplied by pentax medical.The pentax brand silicon oil ptx-of-z11 must always be used for the o-rings of pentax gas/water feeding valves. at this time, pentax medical can only recommend ptx-of-z11 as it is the only lubricant validated by pentax medical for use with these valves. if other oil were applied to the o-ring of ptx-of-b194 this may impact the functionality, and it may cause uncontrolled, continuous gas flow or excessive gas insufflations, resulting in a patient injury such as pneumatic perforation or gas (air) embolism.
  • Action
    Device Technologies is providing updated Instructions for Use with the customer letter. Users are also advised that If the valve does not function properly (does not move smoothly, feels sticky, leaks air or water) remove it and inspect for worn or damaged O-Rings. Replace O-rings as necessary. In case the valve does not function properly during an examination, stop CO2 or water supply at the primary valve (i.e CO2 insufflator or CO2 bombe) immediately.

Device

HOYA Corporation (PENTAX Medical) – Gas/Water Feeding Valve
  • Model / Serial
    HOYA Corporation (PENTAX Medical) – Gas/Water Feeding ValveProduct Codes: PTX-OF-B130 & PTX-OF-B194ARTG Number: 204881
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd