Events

Recall of Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)

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-00135-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00135-1
  • 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
    Intuitive surgical has found that the harmonic ace ifu contains incorrect instructions in regard to the proper use of the instrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counter-clockwise. the correct instruction is to turn the irk clockwise.
  • Action
    Users are asked to discard the current Harmonic Ace IFUs (IFU Part number: 550635-01, 550635-02 550635-03, 550635-04) that they may have. Users are asked to refer to either the Instruments and Accessories User Manual, the Quick Reference Guide that is physically attached to the system, and the metal instruction card that is attached to the IRK provide step-by-step instructions on how to properly perform the emergency grip release.Please also note that the Instruments and Accessories User Manual contain other warnings not listed in the IFU or have information listed in more detail. This action has been closed-out on 15/07/2016.

Device

Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)
  • Model / Serial
    Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)5mm Harmonic ACE instrumentsProduct Codes: INS-400274, INS-4002758mm Harmonic ACE instrumentsProduct Codes: INS-420274, INS-420275Harmonic ACE Curved Shears Disposable InsertProduct Code: INS-400272ARTG number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd