(0804) Complications Associated With AMBU™ Scope Use: An FDA Manufacturer and User Facility Device Experience Analysis

Introduction: Ambu® aScope™ are disposable flexible videoscope used for a wide range of medical procedures with increasing frequency. However, adverse events associated with this device malfunction or improper use can occur.

Methods: 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 January 15, 2023.

Results: In total, 30 unique adverse events were identified. Among these, 21 were classified as being associated with patient injury, and 9 with device malfunction. Of the total, 8 patient reported problems documented as foreign bodies necessitating removal secondary to the aScope, 3 events classified as airway obstruction, desaturation, or hypoxic events, and 1 evented reported as anxiety/cardiac arrest. The majority of adverse events, totaling 27, were associated with bending/breakage/disengagement of the distal tip or scope that necessitated retrieval/removal, and 2 events were associated with fluid leak while administering anesthetic, likely due to defective tubing. The final event involved with the device causing airway obstruction due to physical sticking.

Conclusions: Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a safe and effective tool for airway evaluations. However, they may infrequently serve as a rare form of foreign body with potentially life-threatening consequences. Clinicians should be aware of these potential complications when utilizing this equipment.