复杂症和设备故障与urolift相关:来自MAUDE数据库的调查结果
Patrick Juliebø-Jones1,2, Bhaskar K Somani3, Lazaros Tzelves4
1Department of Urology, Haukeland University Hospital, Bergen, Norway.
Urologia
|June 9, 2023
概括
用于良性前列腺扩大治疗的UroLift系统记录了设备故障和严重并发症,包括死亡. 这一分析强调了改善患者咨询和手术规划的必要性.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 医疗器械安全 医疗器械安全
- 手术并发症 手术并发症
背景情况:
- 良性前列腺扩大 (BPE) 导致膀外流阻塞.
- 该UroLift系统是BPE的最小侵入性治疗方法.
- 报告的优势包括一个简短的学习曲线和日常案例的可行性.
研究的目的:
- 评估与UroLift系统相关的并发症和设备故障.
- 使用国家注册表分析不良事件.
- 为了告知外科实践和患者咨询.
主要方法:
- 美国MAUDE数据库 (2016-2023) 的回顾性审查.
- 对手术器械自愿提交的不良事件报告进行分析.
- 收集关于事件时间,原因,程序完成,并发症和死亡率的数据.
主要成果:
- 记录了103次设备故障,5次手术期间和165次手术后并发症.
- 最常见的问题:植入物无法部署 (56%).
- 严重事件包括尿路塞普斯 (50),血流 (62),中风 (5),肺栓塞 (3),瘤性炎 (1) 和11例死亡.
结论:
- 虽然UroLift系统不如前列腺的穿尿管切除等替代方法具有侵入性,但与严重的不良事件有关,包括死亡率.
- 这些发现为外科医生提供了学习点.
- 建议改善患者咨询和治疗计划.
更多相关视频
07:17Photoselective Vaporesection of the Prostate via an End-firing Lithium Triborate Crystal Laser
Published on: May 9, 2018
8.1K
06:39Technical Modification of the Terminal Ureter During Total Transperitoneal Laparoscopic Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma
Published on: November 22, 2019
7.8K
相关概念视频
Peritoneal Dialysis II: Peritoneal Dialysis Systems and Complications
46
Peritoneal dialysis (PD) is a medical process that removes waste products and excess fluid from the body using the peritoneal membrane as a natural filter.Peritoneal Dialysis MethodsSeveral methods can be used for peritoneal dialysis, including Acute Intermittent Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis, also known as Continuous Cyclic Peritoneal Dialysis.Acute Intermittent Peritoneal Dialysis (AIPD) is used for patients with uremic...
46
Urinary Tract Calculi VI: Surgical Management
11
Procedures for Kidney StonesMedical intervention is necessary when kidney stones or renal calculi are too large to pass spontaneously (typically greater than 5 millimeters) when stones are accompanied by symptomatic infection (such as fever or pyelonephritis), when they impair kidney function, or when they cause persistent symptoms like severe pain, nausea, or urinary retention. Additionally, patients with only one kidney or those who cannot be treated with medical management also require...
11
Urodynamic Studies: Uroflowmetry
117
Uroflowmetry is a non-invasive urodynamic test designed to measure various aspects of urination, including volume, flow rate, and the time to void. This test is crucial for diagnosing and assessing conditions such as bladder outlet obstruction, bladder dysfunction, incomplete bladder emptying, incontinence, and urinary tract blockages caused by benign prostatic hyperplasia (BPH) and urethral strictures.Pre-Test Instructions:Before a uroflowmetry test, patients are typically advised to drink...
117
Urinary Tract Calculi III: Medical Management
9
The diagnosis of renal calculi involves several imaging techniques, including non-contrast CT scans and ultrasound. These methods help visualize kidney stones, assess their size and location, and detect possible obstructions. Additionally, Measuring urine pH is useful for diagnosing specific stone types, such as struvite (alkaline pH) and uric acid stones (acidic pH). Cystine stones are primarily linked to cystinuria, a genetic condition. A urinalysis helps detect blood in the urine (hematuria)...
9
