Events

Recall of Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments Reprocessing Instruction: 551708-01

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00560-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00560-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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