Events

Retiro De Equipo (Recall) de Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments Reprocessing Instruction: 551708-01

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-2015-RN-00560-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-23
  • 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-2015-RN-00560-1
  • 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
    The manufacturer, intuitive surgical inc, has determined that the use of the getinge 88 turbo washer/disinfector in combination with getinge clean mis to reprocess instruments results in a higher chance of input disk breakage, rendering the instrument inoperable. the appendices in the reprocessing manuals incorrectly list the getinge 88 turbo washer/disinfector and the getinge clean mis combination for reprocessing instruments. the getinge combination of equipment and cleaning agents leaves a residual amount of detergent on the input disks resulting in disk breakage during sterilisation.
  • Acción
    Device Technologies Australia (DTA) is requesting the customers to discontinue the use of the Getinge 88 Turbo Washer/Disinfector with Getinge Clean MIS for reprocessing da Vinci Xi instruments. DTA is suggesting alternative reprocessing methods. DTA is also instructing the customers to inspect the input disks of the Endowrist Instruments and identify any broken disks. Device Technologies representative will contact the customer to arrange the returns. This action has been closed-out on 10/08/2016.

Device

Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments Reprocessing Instr...
  • Modelo / Serial
    Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments Reprocessing Instruction: 551708-01ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd