Events

Safety Alert Or Field Safety Notices for Ligasure blunt tip laparoscopic sealer/divider

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 Covidien.

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 Number
    MDA/2011/026
  • Date
    2011-03-15
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-ligasure-blunt-tip-laparoscopic-sealer-divider-potential-risk-of-serious-thermal-burns
  • 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
    During diathermy (electrosurgery) procedures the device may spontaneously energize when clamping, without the activation button being pushed.Although no injuries have been reported, this could cause an unintended energy delivery to tissue resulting in serious thermal burns.
  • Reason
    (covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (mda/2011/026).
  • Action
    The manufacturer is conducting a recall of specific lots.Identify affected devices from the lot numbers indicated on the Field Safety Notice (see appendix). Quarantine any affected devices and arrange for their return to Covidien.The MHRA is issuing this alert as there has been a poor response from users to the recall.

Device

Ligasure blunt tip laparoscopic sealer/divider
  • Model / Serial
  • Product Description
    Ligasure blunt tip laparoscopic sealer/divider.Manufactured by Covidien.Catalogue number: LF1537.Specific lot numbers.
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Manufacturer Address
    Covidien (UK) Commercial Ltd 154 Fareham Road Gosport Hampshire PO13 0AS Tel: 01329 224000 Fax: 01329 224418Email: PRMS.ComplaintsDepartment@covidien.com
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA