Events

Alerte De Sécurité sur Surgical instrument, telemanipulation, Minimally Invasive Surgery. Model PN 400042-01da Vinci Surgical Robots

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Intuitive Surgical Inc.

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
    271
  • Date
    2002-01-18
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Ecri received an account of a member of the system on the electric scalpel blade, which broke during two cardiac surgeries, using the above mentioned apparatus. the blades were left inside the chest cavity and were not recovered. even with malfunction of the device, no injury occurred in the patient. the manufacturer, who is aware of this problem, has done an investigation to determine the cause. he found a situation similar to that described, surgeons are often using an instrument to shave or clean another, causing displacement in the instrument of the unit.
  • Action
    The manufacturer asks to advise surgeons that they should not use an instrument to clean another when the Da Vinci Robot is being used (running). He also provided further instructions and training for surgeons who use the system for the purpose of alerting and underlining this case. Intuitive Surgical has created a new insertion tool, which makes it difficult to drop the blade out of the instrument. The manufacturer claims that this modification has reduced the number of adverse events. For more information or if you have not received the new instructions, training and / or insertion tool, please contact Surgical at 1 (650) 237-7000.

Device

Surgical instrument, telemanipulation, Minimally Invasive Surgery. Model PN 400042-01da Vinci Sur...

Manufacturer

Intuitive Surgical Inc
  • Source
    ANVSANVISA