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 098 08 18 000
  • Event Initiated Date
    2018-08-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13096
  • 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
    This field safety notice is to inform you that intuitive surgical has become aware of specific da vinci s/si and da vinci x/xi monopolar curved scissor (mcs) instruments that may be more susceptible to breakage of the plastic surrounding the instrument shaft (extension tube) which could potentially lead to fragments of the extension tube falling into the patient. this issue only affects the -16 version of the s/si mcs instruments and the -14 version of the x/xi mcs instruments.

Device

da Vinci S/Si 8 mm
  • Model / Serial
    Part Numbers: 420179-16, 470179-14
  • Product Description
    Telemanipulation Systems, Surgical, Minimally Invasive
  • 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