Events

Recall of Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved Scissors

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-00522-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00522-1
  • 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
    Certain versions of the msc instruments may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. the manufacturer identified these micro-cracks during internal testing of an unrelated design modification. these micro-cracks may create a pathway for electrosurgical energy to lead to patient tissue during use and potentially cause thermal injury.
  • Action
    Device Technologies is requesting their customers to follow work around instructions until alternative stock can be provided.

Device

Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved Scissors
  • Model / Serial
    Intuitive Surgical EndoWrist Instrument Hot Shears Monopolar Curved ScissorsPart numbers: 420179-09 and -10, 400179-09 and-10
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd