Events

Recall of da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000

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-01265-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01265-1
  • 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 has identified specific configurations in which monopolar energy has the potential to be transmitted from the da vinci xi endoscope shaft to tissue it is contacting. although there have been no reported complaints related to this issue, these configurations have the potential to result in unintended thermal injury.
  • Action
    The sponsor is advising users to follow the instructions given in the customer letter to mitigate the risk of thermal injury, specifically: • Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced via the 12 mm da Vinci cannula. This is the case whether or not the da Vinci 12 mm to 8 mm cannula reducer is used. • Never insert a da Vinci Xi cannula into another cannula placed in the patient’s body wall (i.e. double cannulation). • Use caution when using monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured. This action has been closed-out on 28/02/2018.

Device

da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000
  • Model / Serial
    da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000Part numbers: 470026-34, 470026-40, 470026-41 DT ordering code: INS-470026 30 deg, 8mm Endoscope, IS4000 Part numbers: 470027-34, 470027-40, 470027-41 DT ordering code: INS-470027 Affected User Manual:Part number: 551706Language: English ARTG: 99242
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd