Events

Recall of da Vinci Xi EndoWrist Stapler

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-2016-RN-01006-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01006-1
  • 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
    There has been an increase in the number of complaints regarding the “stapler firing failed” message for the xi stapler. all cases involving the complaints were completed minimally invasively. one complaint of partial fire resulted in a serious injury when a partial fire across an artery resulted in bleeding (1/12900 xi staple procedures = 0.01%), which was resolved through use of pressure, suture, and a clip.The failure message interrupts the stapler firing prior to completion of the full staple line. when this error occurs, the transection of tissue may be incomplete. in all cases formed staples precede the cut line however; there may be unformed staples at the end of the line. the knife blade could be exposed. while this message can occur with gray, white, blue, or green reloads, the greatest concern is with gray and white reloads, where a partial fire could potentially occur while transecting critical vascular structures such as pulmonary, renal or splenic vessels.
  • Action
    Device Technologies is advising users that In the event of the “Stapler Firing Failed” message, please note the following: 1. While the Stapler remains in the clamped state, it provides compression and tamponades the vasculature. 2. Surgeons should ensure hemostatic and leak control, particularly when around critical vessels with the gray or white reload, before releasing the Stapler from the structure. 3. After unclamping, a blade may be exposed; hence, surgeons should not manipulate tissue with the Stapler after the “Stapler Firing Failed” message occurs. 4. Bedside assistants should take care when removing the fired reload, as sharps hazards, such as potentially exposed knife and unformed staples, may be present. A software correction has been completed as a permanent correction. This action has been closed-out on 03/02/2017.

Device

da Vinci Xi EndoWrist Stapler

Manufacturer

Device Technologies Australia Pty Ltd