Events

Recall of Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use active endotherapy device used in endoscopic procedures for cutting and or coagulating tissue)

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-2014-RN-01174-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01174-1
  • 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
    - during a surgical procedure, if the blade does not return to its original position within a specified timeframe, the system determines the instrument has an “exposed blade”. the da vinci si system is designed to display a recoverable fault when an “exposed blade” error occurs. a recoverable fault means that you may continue using the system after addressing the error. activating and firing the knife blade while the jaws are more than 4 mm open increases the likelihood of an exposed blade error. currently, the vessel sealer applies bipolar energy between the electrode surfaces on the interior surface of the instrument jaws in order to coagulate vessels up to 7 mm in size. users are then instructed to keep the master grips fully closed during the sealing cycle. opening the grip on the masters reduces the pressure applied to the vessel during sealing, which may result in insufficient sealing performance.
  • Action
    Device Technologies Australia is informing their customers of the changes to the user manual to reduce the potential for exposed blade errors and providing a software upgrade to reduce the potential for insufficient sealing. Device Technologies Australia is informing the customers to continue using the Endo Wrist One Vessel Sealer. A Device Technologies Australia product specialist / technician will contact the customer and provide the updated User Manual and schedule the software upgrade which will be available in December 2014. This action has been closed-out on 18/07/2016.

Device

Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use...

Manufacturer

Device Technologies Australia Pty Ltd