Events

Field Safety Notices about DGP-HP RFA High-Power single use grounding pad and Cool-tip RFA Electrode Kits, Cool-tip RF System Electrode kits cluster, Cool-tip RF System Accessories

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Covidien LP.

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
  • Event Date Posted
    2012-09-18
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/09/18/obavestenje-o-meri-povlacenja-sa-trzista-medicinskih-sredstava-koja-sadrze-jastucice-za-uzeml%D1%98enje/
  • 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
    The manufacturer has decided to implement a safety corrective measure in the field, ie withdrawal of the medical device from use, due to the risk posed on the grounding pad, which leads to degradation of the foil and release unwanted heat that can cause burns in patients. covidien received four reports of serious injuries, that is, burns at the location of the electrode pad. cool-type rf system accessories also contains grounding pads so that there is also the risk of an adverse reaction - burns.

Device

DGP-HP RFA High-Power single use grounding pad and Cool-tip RFA Electrode Kits, Cool-tip RF Syst...
  • Model / Serial
    168583 - 213736X, 171281 - 215747X, 168576 - 214355X, 170882 - 214971X, 168571 - 213013X, 169419 - 220740, 168854 - 213368X, 168574 - 214434X, 169684 - 214973, 171300 - 208194X, 168575 - 215632, 168853 - 213703X, 170383 - 213699X, 169683 - 213042X, 169683 - 213042X, 170384 - 215746X, 184240 - 205456, 177906 - 214357X, 191404 - 205455, 162732 - 214867X
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • 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