Events

Recall of Large and Mega Needle Driver Endowrist 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-2013-RN-01294-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01294-1
  • 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 become aware of the potential for detachment of the jaw insert for large needle drivers and mega needle drivers. only large needle driver and mega needle driver instruments manufactured between july 2007 and october 2011 are affected. if a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
  • Action
    Device Technologies is advising users to quarantine affected devices from use. Affected devices can be returned to Device Technologies.

Device

Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems
  • Model / Serial
    Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical SystemsLarge Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420006Mega Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420194Large Needle Driver, da Vinci StandardProduct Number: INS-400006Mega Needle Driver, da Vinci StandardProduct Number: INS-400194.Multiple Lot Numbers affectedManufactured between July 2007 and October 2011ARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd