Events

Safety Alert for da Vinci endoscopic instrument control system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Intuitive Surgical, Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1611-522
  • Event Number
    2016EBC-0014795 ; 2009DM0003498
  • Date
    2016-11-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that the incorrect use of the instrument and operating problems may cause insufficient seal, blade detachment and non-retraction of the system, which may lead to potential delays in surgical times and adverse events for the patient.

Device

da Vinci endoscopic instrument control system
  • Model / Serial
    IS4000-XI, IS3000-SI and SI-E, concerning the EndoWrist sealant, references 410322 and 480322.
  • Product Description
    The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient car and a vision car, it also includes the endoscopes and instrumentosendowrist.
  • Manufacturer
    Intuitive Surgical, Inc

Manufacturer

Intuitive Surgical, Inc