Events

Recall of Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)

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-2013-RN-00890-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00890-1
  • 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 are implementing a revised reprocessing instructions for endowrist instruments and accessories.The changes include:- to allow the use of mildly alkaline enzymatic cleaners, instead of only ph-neutral enzymatic cleaners.- to clarify soaking prior to active scrubbing and rinsing in order to soften soil and make pre-cleaning easier.- to augment scrubbing by spraying water through the isi-supplier luer nozzle at 2 bar pressure onto the tip of the instrument.- to add magnification to the visual inspection of instruments to make it easier to ensure that instruments are free of visible soil prior to automated reprocessing.
  • Action
    Device Technologies Australia is providing on site training for the revised instructions, review updated content and provide a Cleaning and Sanitation kit (including the revised instructions) for all users.

Device

Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic proce...
  • Model / Serial
    Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)Part Numbers of Affected Reprocessing Instructions: 550874-02 and 550882-05ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd