Events

Recall of 5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) 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-00114-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00114-1
  • 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
    Device technologies australia is informing the customers: intuitive surgical has found that the harmonic ace ifu used with the da vinci standard, s, and si surgical systems, contains incorrect instructions in regard to the proper use of the ininstrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counterclockwise. the correct instruction is to turn the irk clockwise.
  • Action
    Device Technologies Australia (DTA) is requesting the users to discard the currentHarmonic ACE IFUs and to follow the instructions from the Instrument and Accessories User Manual, section 9.1. Introduction, paragraph General Precautions and Warnings; that is attached to the system.

Device

5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 a...
  • Model / Serial
    5mm and 8mm Harmonic ACE Instruments IFU (for use with 5mm Harmonic ACE instruments (PNs 400274 and 400275) 8mm Harmonic ACE instruments (PNs 420274 and 420275) and Harmonic ACE Curved Shears Disposable Insert (PN 400272) used with the da Vinci Standard, S, and Si Surgical Systems. Model Numbers: 550635-01; 550635-02; 550635-03; 550635-04
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd