Events

Safety Alert for GlideScope Reusable GVL, AVL, and Ranger Blades

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Verathon.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-27
  • Event Date Posted
    2013-05-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130527a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: verathon glidescope reusable gvl, avl, and ranger blades medical device manufacturer, verathon, has issued a field safety notice concerning all serial numbers of glidescope reusable gvl, avl, and ranger blades. this safety alert applies to all models of glidescope reusable blades currently in the field: reusable gvl 2 0574-0010, gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; avl reusable 2 0574-0118, avl reusable 3 0574-0115, avl reusable 4 0574-0116, and avl reusable 5 0574-0117; and ranger gvl 3 0574-0029, ranger gvl 4 0574-0028, and ranger gvl 4 with 2 foot cable 0574-0018. it does not apply to single use systems, including video batons and stats. the manufacturer has become aware that glidescope video laryngoscope customers continue to use reusable laryngoscope blades even when the blades show signs of serious wear and tear. the statement instructing users to inspect and monitor the product is currently located in the middle of the user’s manual under general maintenance information. this statement may not be sufficiently prominent to ensure that users do, in fact, inspect blades for wear and tear. therefore, verathon initiated a voluntary correction to strengthen the product labeling for all glidescope reusable blade. the manufacturer is highlighting the following warning statement in the user guide: "to ensure patient safety, routinely inspect the glidescope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. if found, do not use the damaged or worn blade, otherwise blade breakage may occur which could cause patient injury or death. always ensure that alternative airway management methods and equipment are readily available." if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 may 2013.

Device

GlideScope Reusable GVL, AVL, and Ranger Blades
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Verathon GlideScope Reusable GVL, AVL, and Ranger Blades
  • Manufacturer
    Verathon

Manufacturer

Verathon