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-2018-RN-00500-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00500-1
  • 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
    In march 2017, device technologies australia (dta) in conjunction with intuitive surgical sent correspondence (tga ref rc-2017-rn-00440-1) highlighting the proper use of the da vinci xi endowrist stapler release kit (srk) tool and providing additional information regarding the use of the instrument release kit (irk) tool as a backup if a srk tool was not available.Further to this, intuitive surgical has now developed an improved da vinci xi endowrist stapler release kit (srk) tool, which reduces the likelihood of breakage. please note that the instructions for use (ifu) remain the same.
  • Action
    Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process. Users are reminded to refer to the IFU for appropriate use of the device.

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 KitObsolete Product Code: INS-381215New Product Code: INS-381215-03Part Number: 381215-02ARTG Number: 228401(Device Technologies Australia - Wrench, surgical)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd