Events

Alerta De Seguridad para DA VINCI Endoscopic Instrument Control System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por manufacturer #121.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1608-332
  • Número del evento
    2009DM-0003498
  • Fecha
    2016-08-05
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • Notas / Alertas
    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.
  • Notas adicionales en la data

Device

DA VINCI Endoscopic Instrument Control System
  • Modelo / Serial
    Concerning the cardiac ablation probe references SG378, SH2360, SH2344, SG664, SH2065, SH1528, || SH2341, SH1153, SH1866, SH2200, SH2362, SH2339, || SH2273, SH2338, SH2312, SH2274, SH2078 and SH1527.
  • Descripción del producto
    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 septal-auricular defects, • coronary artery anastomosis of the left anterior descending artery for coronary revascularization with adjunctive mediastinotomy -directorial representations: the system of Instrument-endoscopic control of INTUITIVE SURGICAL has been used
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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