Events

Retiro De Equipo (Recall) de Sonopet Console (Ultrasonic Surgical Aspirator System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-00769-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-16
  • 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-00769-1
  • 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
    Stryker has noticed a trend of complaints regarding insufficient irrigation to the tip of the sonopet system. lack of irrigation can potentially lead to excessive heat at the tip. in the case where the irrigation pump fails, saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up resulting in tissue burns to the patient.
  • Acción
    Stryker has updated the Instructions for Use (IFU) for Sonopet to include the following clarifications: · DO NOT use a rigid non-collapsible irrigation container. Failure to comply may cause the flow of irrigation to be drastically reduced and result in overheating of the handpiece tip and/or tip cover. Only use a collapsible irrigation container. · The irrigation tube must be properly routed through the irrigation pump with the pump cover fully closed and latched. Improper setup of the irrigation tubing may result in an inconsistent or lack of irrigation. · Provide adequate irrigation to the tip to avoid excessive heat that could result in tissue damage due to unintended contact. Additionally, all existing Sonopet consoles will have an instructional irrigation setup label applied to the side of the console. This action has been closed-out on 03/06/2016.

Device

Sonopet Console (Ultrasonic Surgical Aspirator System)
  • Modelo / Serial
    Sonopet Console (Ultrasonic Surgical Aspirator System)Catalogue Number: 5450852000All Serial NumbersARTG Number: 174364
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA