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 manufacturer #121.

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
    I1503-136
  • Event Number
    2009DM-0003498
  • Date
    2017-03-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • 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

Device

DA VINCI Endoscopic Instrument Control System
  • Model / Serial
    references 420022-02, 420256- 01, 420258-01, 420026-01, 420279-03, 420273-02, 420290- || 03, 420291-03, 420281-02, 420015-03, 400027-04, 400016- || 04 and 400015-03
  • Product Description
    The purpose of the INTUITIVE SURGICAL endoscopic instrument control system is to help accurately control INTUITIVE endoscopic instruments, such as rigid endoscopes, endoscopic dissectors and incisors, scissors, scalpels, forceps / clamps, needle handling tools, endoscopic retractors, stabilizers, accessories for electrocautery and for endoscopic manipulation, for example to hold them, cut them, perform a blunt or incisal excision, bring them closer, ligate them, electrocauterize them and suture them during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopic assisted cardiotomy interventions. 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 physicians in surgical environments, using the representative and specific procedures described in the instructions for use. INTUITIVE SURGICAL's endoscopic instrument control system has been successfully used, among others, in the following procedures; • radical prostatectomy, pyeloplasty, cystectomy, nephrotomy, urethral reimplantation • cholecystectomy, Nissen fundoplication, Heller's myotomy, gastric deviation, donor nephrotomy, adrenalectomy, splenectomy, and intestinal resection. • hysterectomy, myomectomy, sacrocopopaxy • mobilization of the internal mammary artery, ablation of cardiac tissue • repair of the mitral valve, endoscopic closure of atrial septal defects, • breast anastomosis of the left anterior descending coronary artery for cardiac revascularization with adjunctive mediastinotomy -representative pediatric: the control system of endoscopic instruments of INTUITIVE SURGICAL has been
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA