Events

Recall of DA VINCI SI SYSTEM - PATIENT CART

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MINOGUE MEDICAL INC..

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
    15507
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    During normal use of the robotic platform used for da vinci surgery (patient cart) it can be exposed to small amounts of fluids from the environment (during cleaning for example) without impairing function. improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers. during surgical procedures there is also a small risk that fluid can be transferred inside the patient cart for example biological or i.V. fluids.

Device

DA VINCI SI SYSTEM - PATIENT CART
  • Model / Serial
    Model Catalog: IS3000 (Lot serial: 253388)
  • Product Description
    Da Vinci SI System - Patient Cart
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.