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 056 10 13 000
  • Event Initiated Date
    2013-10-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4494
  • 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
    A review of internal records has indicated that from march 15th to july 19th 2013, the correct user manual associated with the single-site® instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments. this correction does not impact the performance of the affected instruments and no product removal is required. the actual risk of use of the new instruments without the correct documentation is minimal as the same or similar content is included with the is3000 instruments and accessories user manual as well as the single-site® marketing materials.

Device

Single use , Endotherapy electrosurgical diathermy system electrode . Bipolar Maryland
  • Model / Serial
    Product Number/Catalog Number : 428080-04 , 428088-12 from 15 March through 19 July 2013
  • Product Description
    Single use , Endotherapy electrosurgical diathermy system electrode . Bipolar Maryland
  • 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