Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Intuitive Surgical Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 029 12 15 000
  • Event Initiated Date
    2015-12-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8594
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Upon becoming aware of publ ications identifying a risk of capacitive coupling from monopolar energy sources to endoscopes in laparoscopic surgery, intuitive surgical initiated an investigation to determine if this risk applies to existing da vinci technologies. as a result of this investigation, intuitive surgical has identified specific configurations in which monopolar energy has the potential to be transmitted fro m the da vinci xi endoscope shaft to tissue it is contacting.

Device

da Vinci® Xi™ endoscope and cannulae configurations
  • Model / Serial
    Product Name : 8mm Endoscope, 0° Part Number : 470026-34, 470026-40, 470026-41 Product Name : 8mm Endoscope, 30° Part Number : 470027-34, 470027-40, 470027-41
  • Product Description
    endoscopes
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Manufacturers representative
    Gulf Medical Co, Jeddah (012)6512828
  • Source
    SFDA