Source of the article: Siyu MedTech; Editor:Liu XinyiReprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
On November 14, 2023, the U.S. FDA announced:ItFrontMedtronic Announces Stolen McGrath Mac Video Laryngoscopes Now Considered Class I Recall.(The most serious category in the recall classification, indicating that the product may cause serious health problems or even death).
# Review of the Video Laryngoscope Theft Incident
At the end of September 2023, Medtronic issued a safety notice online to inform the public of a batch of defectiveMcGRATH™Mac Video Laryngoscope Stolen, Currently Being Illegally Sold on Multiple Social Media Websites by Some Unauthorized Third Parties.
Medtronic stated that these products, which failed quality tests and were supposed to be destroyed, were stolen before they could be processed. Details of the laryngoscope theft have not yet been disclosed.
McGRATH™Mac Video Laryngoscope is a device that assists in tracheal intubation. It uses a light source that mimics natural light, with the display resolution enhanced more than three times. The built-in lens offers a wide field of view, and it automatically powers off when not in use, extending battery life. Additionally, the battery level can be displayed in minutes.
The FDA stated that the use of non-conforming devices could pose risks to patients, potentially leading toLaryngoscopy failure, intubation failure`, further causing`Respiratory failure (including hypercapnia), hypoxia (causing bradycardia, arrhythmia), hypercapnia, tissue injury/trauma, and treatment delay (prolonged operation time/hospital stay)。Medtronic listed the complete list of 1,600 affected product serial numbers and also noted that products with missing serial numbers are included. The stolen products are packaged without labels (the label indicates: CONFORMING devices can be identified by the presence of a serial number and are packaged in either version of the container shown).The company advises customers to purchase the device only from trusted channels such as Medtronic or authorized distributors of Medtronic to avoid defective products.Medtronic stated at the time that it was working with regulatory and law enforcement agencies to identify and remove advertisements for problematic products and to recover stolen products. However, it may be too late to retrieve all stolen devices. Medtronic warned healthcare providers and patients against participating in any procedures involving endoscopic catheters, as this could lead to serious complications or even death. Additionally, Medtronic urged the public to provide information related to the promotion or sale of stolen products.Medtronic's Covidien business unit initiated a recall on September 28, 2023. This recall affected5,709 devices distributed in the United States between July 5, 2019, and July 14, 2022。FDA States That Substandard Laryngoscopes Are Being Sold on Social Media Platforms, Including Facebook Marketplace. After Some Devices Were Recovered Following the Discovery of the Theft, Social Media Posts Were Removed, but the Whereabouts of These Devices Remain Unknown.On October 17, the official website of the National Medical Products Administration showed that Covidien Medical Devices International Trade (Shanghai) Co., Ltd. reported that some disposable video laryngoscopes that should have been destroyed were sold by a third-party destruction company on overseas social media platforms without approval in Mexico. This has led to potential patient harm. The manufacturer, Plexus Electronica S.de R.L.de C.V., initiated a voluntary recall of its produced video laryngoscope, McGRATH MAC Video Laryngoscope (Registration No.: Guo Med Reg In 20222080633). The recall level is classified as a Level 1 recall.
However, the FDA said that it has not received any complaints about defective devices so far, and Medtronic also stated that there are no related casualties.Report. The FDA notice explained that, since the defective products were supposed to be destroyed, Medtronic was not aware of the specific conditions of the defective products. Therefore, Medtronic did not rule out the possibility that the defective devices could primarily lead to insufficient tracheal support, cardiopulmonary arrest, and death. High-risk groups include individuals with high metabolic rates and low pulmonary reserves, such as children, pregnant women, obese individuals, and critically ill patients.
