Events

Alerte De Sécurité sur DA VINCI Endoscopic Instrument Control System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par manufacturer #121.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1608-332
  • Numéro de l'événement
    2009DM-0003498
  • Date
    2016-08-05
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=127
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données

Device

DA VINCI Endoscopic Instrument Control System
  • Modèle / numéro de série
    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.
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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