Events

Field Safety Notices about Cranial Instrument Set Combo

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by MEDTRONIC 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
    Field Safety Notice
  • Date
    2013-02-08
  • Event Date Posted
    2013-12-12
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/ciril/2013/12/12/%D0%BE%D0%B1%D0%B0%D0%B2%D0%B5%D1%88%D1%82%D0%B5%D1%9A%D0%B5-%D0%BE-%D0%BC%D0%B5%D1%80%D0%B8-%D0%BF%D0%BE%D0%B2%D0%BB%D0%B0%D1%87%D0%B5%D1%9A%D0%B0-%D1%81%D0%B0-%D1%82%D1%80%D0%B6%D0%B8%D1%88%D1%82-17/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    When validating a new instrument, testing has shown that the gravitative steam sterilization procedure in one of the aforementioned instrument cassettes does not achieve the sterilization rate (sal) of 106 recommended by industry standard (ansi / aami st77: 2006 and en 556-1 : 2001). subsequent examination of all "medtronic xomed" additional instrument cassettes revealed that there were certain locations in the cassette where the recommended degree of sal106 sterilization during the gravitative steam sterilization process could not be achieved. it is these cassettes identified by the test that are the subject of this action.

Device

Cranial Instrument Set Combo

Manufacturer

MEDTRONIC INC.
  • 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
    ALIMSA