Events

Rappel de HOYA Corporation (PENTAX Medical) – Gas/Water Feeding Valve

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00711-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00711-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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