Events

Retiro De Equipo (Recall) de STERIS Quick Connects (used with the Steris System 1 Express and System 1 Plus sterilisers)

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-2016-RN-00251-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-03-04
  • 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-2016-RN-00251-1
  • 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
    Quick connects provide directed flow of sterilant use dilution and rinse water into the internal lumens of specifically identified endoscopes to achieve liquid chemical sterilisation.Steris has learned that one of the hysteroscope models (karl storz 11264bbu1) listed for processing in stqkc1736int and st-qkc-1737int has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions. a user who connects the karl storz 11264bbu1 hysteroscope according to the processing instructions will observe an unused quick connect port adapter. steris performed testing on the karl storz 11264bbu1 hysteroscope which confirmed that despite this unused port adapter, the flow provided to the lumen is more than adequate. therefore, the efficacy of the liquid chemical sterilisation process is not affected. however, there is potential for user confusion due to the unused quick connect port adaptor if used for this hysteroscope.
  • Acción
    Device Technologies is advising users that updated labelling kits and instructions for use will be provided. The impacted hysteroscope can be processed using the ST-QKC-1705INT processing manual. This action has been closed-out on 30/01/2017.

Device

STERIS Quick Connects (used with the Steris System 1 Express and System 1 Plus sterilisers)
  • Modelo / Serial
    STERIS Quick Connects (used with the Steris System 1 Express and System 1 Plus sterilisers)Product Codes: ST-QKC1736INT and ST-QKC-1737INTARTG Number: 113489
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd