Related Experiment Video
Updated: Jun 21, 2025
Image Acquisition using Portable Sonography for Emergency Airway Management
Published on: September 28, 2022
Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis
David R Grimm1, Akash S Halagur1, Noel Ayoub2
1Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Palo Alto, California, USA.
Abstract:
Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient-related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty-one of the events were associated with patient injury, and 9 with device malfunction. Eight patient-reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life-threatening consequences.
Insights
The Ambu aScope, a disposable videoscope, is effective for airway evaluations but can rarely cause serious patient injury, including foreign body events. Vigilance is crucial to mitigate these risks.
Area of Science:
- Medical Devices
- Patient Safety
- Pulmonology
Background:
- The Ambu aScope is a widely used disposable flexible videoscope in various medical procedures.
- While effective, adverse events associated with its use have been reported.
- Understanding these events is crucial for patient safety.
Purpose of the Study:
- To analyze patient-related adverse events associated with the Ambu aScope using the FDA MAUDE database.
- To identify the types and frequencies of adverse events linked to Ambu aScope use.
- To assess the potential risks and consequences of these adverse events.
Main Methods:
- Retrospective analysis of the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
- Inclusion criteria: Patient-related adverse events involving Ambu aScope from January 1, 2000, to December 15, 2023.
- Search terms: "Ambu" and "Ascope."
Main Results:
- Thirty unique adverse events were identified.
- Twenty-one events involved patient injury; nine involved device malfunction.
- Key injuries included foreign body events (8), airway obstruction/hypoxia (3), and anxiety/cardiac arrest (1).
Conclusions:
- The Ambu aScope is a valuable tool for airway evaluations.
- Rarely, it can act as a foreign body, leading to severe patient harm.
- Continuous monitoring and reporting of adverse events are essential for improving device safety.
Related Concept Videos
01:26Endoscopic Studies II: Thoracocentesis
Description
Excess pleural fluid or air may accumulate in some respiratory disorders in the thoracic cavity. To treat pleural effusion, a physician conducts thoracentesis by carefully piercing the chest wall and entering...
01:30Assessment of Airway, Skin Color, and Use of Accessory Muscles
Introduction
The initial evaluation of a patient's respiratory system...
01:29Endoscopic Procedures I: Esophagogastroduodenoscopy
During an EGD, the endoscope can be used to: