Events

Safety Alert Or Field Safety Notices for Burr hole probe cover with gel

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Microtek Medical Europe.

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/076
  • Event Number
    CON329263
  • Date
    2013-10-24
  • Event Date Posted
    2013-10-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON329263?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of exposure to endotoxin levels above acceptable limits if the ultrasound probe cover comes into contact with the central nervous system. the manufacturer has identified that the affected ultrasound probe covers have not undergone adequate endotoxin testing. microtek medical europe issued a field safety notice (fsn) dated 10 july 2013 but has not received sufficient confirmation from users that they have received and acted on this information.
  • Action
    Ensure that relevant staff are aware of this Field Safety Notice. Identify all affected batches of these ultrasound probe covers. Quarantine all affected batches. Complete the recall response form and return it to Microtek Medical Europe as soon as possible. Follow the manufacturer’s instructions for returning the affected devices. Action by: Operating theatre staff and surgical staff Neurosurgery departments Spinal surgery departments Radiology departments Supplies departments

Device

Burr hole probe cover with gel
  • Model / Serial
  • Product Description
    Ultrasound probe cover: Burr hole probe cover with gel. These ultrasound probe covers are disposable, single-use drapes. They are used as a cover for ultrasound probe scan heads and power cords, used for various surgical procedures, to provide a barrier over the equipment. Product reference (SKU number): 3688UK, PC3688, PC3688EU. Affected batch numbers are listed in the Field Safety Notice (FSN). Note that product ref (SKU number) 3688 is listed in the FSN but it is not for sale in the UK.
  • Manufacturer
    Microtek Medical Europe

Manufacturer

Microtek Medical Europe