Events

Recall of da Vinci Xi EndoWrist Stapler Release Kit (SRK)

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-2017-RN-00440-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00440-1
  • 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
    The manufacturer, intuitive surgical has received complaints where the srk tool has broken during use. it was determined that misinterpretation of instructions provided on the is4000 srk instruction card may result in damage of the tool. there have been three clinical cases where the endowrist stapler jaws would not open while clamped on tissue, the srk tool broke, and the stapler was excised using an alternative stapling device or other surgical intervention. the risk to health due to the srk tool breakage can range from the minor delay in surgery in order to locate and use a backup srk or instrument release kit (irk) tool, to extracting the clamped tissue from the stapler jaws, to the worst case scenario of the clamped tissue needing to be excised using an alternative stapling device or other surgical intervention. device technologies wish to reiterate the proper use of the srk tool, and to provide additional instructions in the scenario of srk tool damage.
  • Action
    Device Technologies is advising users in the scenario where the SRK needs to be used, to follow all instructions as provided in the da Vinci Xi EndoWrist Stapler Instruments and Accessories User Manual Addendum and reiterated in the customer letter. If the SRK tool breaks, proceed with the instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and contact your Device Technologies representative to arrange for SRK return through the product complaints process.

Device

da Vinci Xi EndoWrist Stapler Release Kit (SRK)
  • Model / Serial
    da Vinci Xi EndoWrist Stapler Release Kit (SRK)Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release KitProduct Code: INS-381215Part Number: 381215-02ARTG Number: 228401
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd