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.

Autor: Juliebø-Jones P; Department of Urology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway; EAU YAU Urolithiasis Group, Arnhem, Netherlands. Electronic address: jonesurology@gmail.com., Somani BK; Department of Urology, University Hospital Southampton, UK., Tzelves L; Second Department of Urology, National and Kapodistrian University of Athens, Sismanogleio General Hospital, Athens, Greece; EAU YAU Urolithiasis Group, Arnhem, Netherlands., Æsøy MS; Department of Urology, Haukeland University Hospital, Bergen, Norway., Gjengstø P; Department of Urology, Haukeland University Hospital, Bergen, Norway., Moen CA; Department of Urology, Haukeland University Hospital, Bergen, Norway., Beisland C; Department of Urology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway., Ulvik Ø; Department of Urology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Jazyk: angličtina
Zdroj: Urology [Urology] 2023 Jul; Vol. 177, pp. 41-47. Date of Electronic Publication: 2023 Apr 11.
DOI: 10.1016/j.urology.2023.03.028
Abstrakt: 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.
Competing Interests: DECLARATION OF COMPETING INTEREST Patrick Juliebø-Jones - no conflict. Bhaskar K Somani - no conflict. Lazaros Tzelves - no conflict. Mathias Sørstrand Æsøy - no conflict. Peder Gjengstø - no conflict. Christian Arvei Moen - no conflict. Christian Beisland - no conflict. Øyvind Ulvik - Paid consultant to Sponsor Olympus. Olympus had no involvement in this study.
(Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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