Events

Recall of Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MAC S4 Single Blade and Box of 10

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Verathon Medical Australia 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-2016-RN-00133-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00133-1
  • 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
    The affected glidescope (gs) titanium (ti) single use (su) video laryngoscope blades may cause significant disruption (flickering) in the video laryngoscopy image during an intubation procedure.If a glidescope titanium su blade causes image flickering during an intubation procedure, there may be a short delay while the physician completes the intubation with a disrupted video image. if flickering is so severe that the video image cannot be relied upon to complete the intubation, then the failure of the intubation procedure, and accompanying delay while a different su blade or laryngoscope is located, could result in patient death or serious injury. at this time, verathon is not aware of any instances of patient injuries or deaths attributed to this potential failure.
  • Action
    Verathon is advising users to inspect stock and quarantine the affected units prior to their return. Verathon will replace the affected units. This action has been closed-out on 09/05/2017.

Device

Glidescope Titanium Single-Use Video Laryngoscope Blades Product: LoPro S3, LoPro S4, MAC S3 & MA...
  • Model / Serial
    Glidescope Titanium Single-Use Video Laryngoscope BladesProduct: LoPro S3, LoPro S4, MAC S3 & MAC S4Single Blade and Box of 10Multiple Model NumbersMultiple Lot NumbersARTG Number: 235136
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Verathon Medical Australia Pty Ltd

Manufacturer

Verathon Medical Australia Pty Ltd