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 064 05 16 000
  • Event Initiated Date
    2016-05-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9339
  • 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
    Intuitive surgical identified particulate during quality inspections of the insufflation stopcock on the da vinci xi 5 mm-8 mm universal seal. the particulate has the potential to be introduced into the cannula lumen when insufflation is connected. although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. during abdominopelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (hdpe) particulate, its small size and the benign particulate geometry.

Device

da Vinci Xi Universal Seal
  • Model / Serial
    da Vinci Xi 5 mm-8 mm Universal Seal (PN 470361-05 and 470361-06) and da Vinci Xi 12 mm & Stapler Universal Seal (PN 470380-05 and 470380-06)
  • Product Description
    Surgical Endoscope Instrument Control System
  • 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