Events

Retiro De Equipo (Recall) de HOYA Corporation (PENTAX Medical) – Gas/Water Feeding Valve

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00711-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00711-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / 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