GlideScope Video Laryngoscope Recall Issued Over Defective Blades
Small cameras used to view the inside of the throat and vocal cords during surgery have been recalled because defective “blades” used to secure them in the patients’ mouths could break, putting patient lives at risk.
The FDA announced a class 1 recall of several GlideScope Video Laryngoscope blades on July 10, indicating that there was a risk of tip breakage.
The GlideScope Video Laryngoscope (GVL) 3,4, 5 and the GlideScope Advanced Video Laryngoscope (AVL) 2,3,4 and 5 blades were recalled after the manufacturer, Verathon, Inc., issued an “Urgent Medical Devices Recall” letter to customers on May 10. The letter advised customers of possible blade failure.
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A laryngoscope is a tube shaped device with a camera attached to the end. The device is inserted into a patient’s throat to give doctors an internal view of the throat and the vocal cords for medical procedures.
The part that is called the “blade” is not an actual surgical blade used for cutting, but refers to the edge of the laryngoscope that is flattened to fit into a patients mouth.
The recall affects all GlideScope Video Laryngoscope GVL and AVL Reusable manufactured and distributed from August 1, 2011, through June 30, 2012.
According to the manufacturer’s warning, the broken blades may not be obvious when inspected before or after using the laryngoscope. Pieces of the blade can break of while in patients mouths and block airways.
The breakage also makes patients more prone to swallowing the broken pieces, causing further side effects, such as low blood oxygen levels (hypoxemia), severe cuts in the airway which can cause loss of blood and even death.
A class 1 recall is the most serious type of recall which the FDA can issue. It is designated when a medical device poses serious threat of causing severe side effects and may even result in death in many cases.
The Bothell, WA. Based company advised its customers to stop using the affected devices immediately, return any affected devices to be replaced along with submitting the return response form.
Healthcare professionals have been advised to immediately report any adverse events which result from using the affected problem to the FDA MedWatch program. Customers with questions can call Cerathon Customer Care at (800) 331-2313 or e-mail the company at email@example.com.
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