Events

Safety Alert Or Field Safety Notices for Ethicon Curved Intraluminal Staplers

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 Ethicon.

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
  • Date
    2019-04-25
  • Event Date Posted
    2019-04-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/ethicon-curved-intraluminal-staplers-risk-of-failure-of-staple-lines-mda-2019-019
  • 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
    Affected devices have been manufactured since March 2018 with expiry dates in 2023. The problem was identified following increased complaints of malformed staples and returned devices from customers. The manufacturer expects failure rate to remain below 0.1%. A root cause investigation is ongoing.
  • Reason
    Manufactured by ethicon – use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding.
  • Action
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice dated 29 March 2019.Actions are:Identify and quarantine all affected, unused devices as listed in the Field Safety Notice. If alternative devices are available, use the alternatives and return affected products to Ethicon. If alternative devices are not available, only use affected products following local risk assessment and in adherence to the guidance provided in the Field Safety Notice. Complete the Business Response Form and return to Ethicon.Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Ethicon Curved Intraluminal Staplers
  • Model / Serial
  • Product Classification
    General and Plastic Surgery Devices
  • Product Description
    In addition to the Field Safety Notice which details affected product, please refer to the spreadsheet which accompanies this Medical Device Alert for additional unique device identification information.
  • Manufacturer
    Ethicon

Manufacturer

Ethicon
  • Manufacturer Address
    Ethicon LLC, Johnson & Johnson MedicalTel: 0113 387 6261Email: MDFieldActionsUKIrl@its.jnj.com
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    MHRA