Urology · 2023
Device Failure and Adverse Events Related to Single-use and Reusable Flexible Ureteroscopes: Findings and New Insights From an 11-Year Analysis of the Manufacturer and User Facility Device Experience Database.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Juliebø-Jones Patrick, Somani Bhaskar K, Tzelves Lazaros, Æsøy Mathias Sørstrand, Gjengstø Peder, Moen Christian Arvei, Beisland Christian, Ulvik Øyvind
Аннотация
OBJECTIVE: To catalog and characterize device failures and adverse events related to flexible ureteroscopes from a national database.
METHODS: Search of the Manufacturer User and Facility Device Experience database was performed for all recorded events related to flexible ureteroscopes between 2012 and 2022. The following information was collected: Problem and cause, timing, complications and injury, prolonged anesthesia, and early termination of procedure. Event severity was graded using a validated tool.
RESULTS: A total of 206 events were identified (reusable/single use ratio, 2.5:1). There were 20 different problem categories reported, which included image loss (26.7%), difficulty removing scope (13.6%), scope damage from basket (4.4%), detachment of scope tip (5.8%) and contamination (4.9%). Faulty device was the predominant cause for an event related to single-use scopes (86.4%); this was seldom the case for reusable (2%). Patient injury occurred in 21.8%, but these were all in reusable scopes. No deaths were reported, but major complications included complete avulsion of the ureter (3.4%) and fully entrapped scope necessitating open surgery (2.9%). While the safety profile for single-use scopes was superior, they were significantly more likely to result in early termination (71.1% vs 37.3%, P < .001). This was related to 76.3% of the single-use scopes experiencing sudden image loss.
CONCLUSION: Flexible ureteroscopes are fragile, and a multitude of problems can occur. Many of these can be avoided through correct surgeon technique and robust maintenance services.
METHODS: Search of the Manufacturer User and Facility Device Experience database was performed for all recorded events related to flexible ureteroscopes between 2012 and 2022. The following information was collected: Problem and cause, timing, complications and injury, prolonged anesthesia, and early termination of procedure. Event severity was graded using a validated tool.
RESULTS: A total of 206 events were identified (reusable/single use ratio, 2.5:1). There were 20 different problem categories reported, which included image loss (26.7%), difficulty removing scope (13.6%), scope damage from basket (4.4%), detachment of scope tip (5.8%) and contamination (4.9%). Faulty device was the predominant cause for an event related to single-use scopes (86.4%); this was seldom the case for reusable (2%). Patient injury occurred in 21.8%, but these were all in reusable scopes. No deaths were reported, but major complications included complete avulsion of the ureter (3.4%) and fully entrapped scope necessitating open surgery (2.9%). While the safety profile for single-use scopes was superior, they were significantly more likely to result in early termination (71.1% vs 37.3%, P < .001). This was related to 76.3% of the single-use scopes experiencing sudden image loss.
CONCLUSION: Flexible ureteroscopes are fragile, and a multitude of problems can occur. Many of these can be avoided through correct surgeon technique and robust maintenance services.