Events

Recall of Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci 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-2014-RN-00520-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00520-1
  • 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 (dta) in conjunction with the manufacturer, intuitive surgical inc., is issuing this recall for product correction for 5mm curved cannula for single-site instruments, to update the user manual. as indicated in the user manual addendum, cannula damage can include cracks in the tube or bowl/tube interface and tube wall anomalies etc and may result from incorrect placement of the cannulae. if cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue and generate excessive forces on the patient body wall. this contact may cause tissue injury and require additional surgical and/or medical intervention.
  • Action
    The “Single-Site Cannula Inspection and Use – Single-Site User Manual Addendum” will be hand delivered to the Nurse Unit Manager by your Product Specialist.

Device

Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Sy...
  • Model / Serial
    Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical SystemsAffected Products:INS-428061 5 X 300MM CURVED CANNULA ARM 1INS-428062 5 X 300MM CURVED CANNULA ARM 2INS-428071 5 X 250MM CURVED CANNULA ARM 1INS-428072 5 X 250MM CURVED CANNULA ARM 2ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd