Events

Safety Alert for Product trade name: ROBÓTICO SURGICAL SYSTEM DA VINCI - INTUITIVE SURGICAL /// Record number: 10302860146 /// Affected lots: SG378; SH2360; SH2344; SG664; SH2065; SH1528; SH2341; SH1153; SH1866; SH2200; SH2362; SH2339; SH2273; SH2338; SH2312; SH2274; SH2078; SH1527 / / / Product hazard class: III.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by H. Strattner & Cia LTD.; Intuitive Surgical Inc..

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
    1880
  • Date
    2016-04-26
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    To manipulate a cardiac ablation probe, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
  • Reason
    The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
  • Action
    Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.

Device

Product trade name: ROBÓTICO SURGICAL SYSTEM DA VINCI - INTUITIVE SURGICAL /// Record number: 103...

Manufacturer

H. Strattner & Cia LTD.; Intuitive Surgical Inc.
  • Source
    ANVSANVISA