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
  • Numéro de l'événement
    2016EBC-0014795 ; 2009DM-0003498
  • Date
    2017-10-02
  • 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=70
  • 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
    EndoWrist Stapler Release Kit (SRK)
  • Description du dispositif
    The purpose of the INTUITIVE SURGICAL endoscopic instrument control system is to help accurately control endoscopic instruments of INTUITIVE, 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 of tissues, for example for holding, cutting, performing a blunt or incisive dissection, bringing them closer, ligating, electrocautery and suturing them during general laparoscopic surgical procedures, general nocardiovascular thoracoscopic surgical interventions and cardiotomy interventions with angio-assisted assistance. The system can also be used adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and in pediatrics. It is designed to be used by qualified doctors in surgical environments, using the representational and specific procedures described in the instructions for use. The endoscopic instrument control system of intuitive surgical seprocedures; Radical prostatectomy, pyeloplasty, cystectomy, nephrotomy, urethral reimplantation Cholecystectomy, Denissen fundoplication, HELLER myotomy, gastric bypass, Hysterectomy nephrectomy, myomectomy, sacrocopopaxy Mobilization of the internal mammary artery, cardiac tissue ablation Valve repairMast anastomosis of the left anterior descending coronary artery for cardiac revascularization with adjunctive mediastinotomy
  • 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