Events

Safety Alert Or Field Safety Notices for Stapler Duet TRS™ universal straight and articulating single use loading units (SULU)

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/2012/005
  • Date
    2012-02-16
  • 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-stapler-duet-trs-universal-straight-and-articulating-single-use-loading-units-sulu-do-not-use-for-adult-or-paediatric-thoracic-surgery-procedures
  • 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
    Covidien has issued advice (369Kb) following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening post-operative complications.
  • Reason
    (covidien) reports of serious injuries after use of stapler duet trs™ loading units in the thoracic cavity.(mda/2012/005).
  • Action
    Do not use these Duet TRSTM Loading Units for any adult or paediatric thoracic surgery procedures. Return any products purchased solely for thoracic use to the manufacturer, following the instructions in the manufacturer’s advice (369Kb).

Device

Stapler Duet TRS™ universal straight and articulating single use loading units (SULU)
  • Model / Serial
  • Product Description
    StaplerDuet TRS™ universal straight and articulating single use loading units (SULU)Manufactured by CovidienProduct codes and descriptions of affected devices:Product code   Description DUET4535   Duet TRS™ 45 3.5mm straight SULU DUET4535A   Duet TRS™ 45 3.5mm articulating SULU DUET4548   Duet TRS™ 45 4.8mm straight SULU DUET4548A   Duet TRS™ 45 4.8mm articulating SULU DUET6035   Duet TRS™ 60 3.5mm straight SULU DUET6035A   Duet TRS™ 60 3.5mm articulating SULU DUET6048   Duet TRS™ 60 4.8mm straight SULU DUET6048A   Duet TRS™ 60 4.8mm articulating SULU
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Manufacturer Address
    Amanda Woolven Covidien Commercial (UK) Ltd 4500 Parkway Whiteley Hampshire PO15 7NY Tel: 01329 224 435 Fax: 01329 224 418Email: Amanda.woolven@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