Events

Recall of Multiple AxiEM ENT Suction Instruments Straight Suction EM, ENTCurved Suction 70 EM, Short Curved Suction 90, EM Suction Small Straight AxiEM ENT

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00861-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00861-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Medtronic has become aware that the specific lots of axiem ent suction instruments are not able to pass instrument verification. instrument verification is a step in the software which is performed prior to the use of each instrument. this verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. the impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (em) tracking capability of the stealthstation.If this issue presents during surgery, it may result in surgery being extended to troubleshoot the issue, discontinuation of navigation, or aborting surgery if alternative instruments are not available to proceed. to date, there have been no reports of patient injury.
  • Action
    Medtronic is requesting customers examine their inventory and if any of the affected products listed in the customer letter are found, immediately cease use and quarantine them for return to Medtronic. Alternatively, each local Medtronic Sales Representative will perform this step. If the product has been removed from its original packaging, the part number and lot number can be found printed directly on the device as shown in the pictures given in the customer letter.

Device

Multiple AxiEM ENT Suction Instruments Straight Suction EM, ENTCurved Suction 70 EM, Short Curved...
  • Model / Serial
    Multiple AxiEM ENT Suction InstrumentsStraight Suction EM, ENTCurved Suction 70 EM, Short Curved Suction 90, EM Suction Small Straight AxiEM ENTMultiple Part and Lot NumbersThese instruments may also be included in the following kits:ENT Instrument SetFusion ENT Instrument KitENT AxiEM Instrument SetENT Prgm Add Fusion Nav AxiEMARTG Numbers: 129428, 125074 & 120114
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA