Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis
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Wiley Open Access
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| Formato: | Artículo Open Access |
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Wiley
2024
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| _version_ | 1867004654022295552 |
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| author | David R. Grimm Akash S. Halagur Noel Ayoub |
| author_facet | David R. Grimm Akash S. Halagur Noel Ayoub David R. Grimm Akash S. Halagur Noel Ayoub |
| collection | Wiley Open Access |
| contents | Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis David R. Grimm Akash S. Halagur Noel Ayoub Otolaryngology–Head and Neck Surgery AbstractAmbu® 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. 10.1002/ohn.898 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| doi_str_mv | 10.1002/ohn.898 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_ohn_898 |
| institution | Wiley Open Access |
| license_str_mv | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis David R. Grimm Akash S. Halagur Noel Ayoub Otolaryngology–Head and Neck Surgery Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis David R. Grimm Akash S. Halagur Noel Ayoub Otolaryngology–Head and Neck Surgery AbstractAmbu® 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. 10.1002/ohn.898 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| title | Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis |
| topic | Otolaryngology–Head and Neck Surgery |
| url | https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.898 |