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 045 09 15 000
  • Event Initiated Date
    2015-09-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=8213
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Intuitive surgical has received a small number of complaints regarding the “exposed knife blade” recoverable fault for the xi stapler with xi system p4 version software. with this “exposed knife blade” recoverable fault, the stapler firing is interrupted prior to the completion of the full staple line. with this known, recoverable fault, formed staples precede the cut line; however, an exposed knife blade remains with incomplete staple formation at the distal end.

Device

Vinci Xi Surgical System

Manufacturer

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