Singh Achintya D, Madhu Deepak, Pathiyil Mythili Menon, Ramai Daryl, Mohan Babu P, Shah Bhavesh, Adler Douglas G
Gastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Gastroenterology, Lisie Institute of Gastroenterology, Lisie Hospital, Kochi, Ernakulam, India.
Endosc Ultrasound. 2023 Sep-Oct;12(5):424-427. doi: 10.1097/eus.0000000000000016. Epub 2023 Aug 12.
The safety of endoscopic ultrasound-guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question.
The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions.
There were 344 device-related issues. Most issues were due to detachment or breakage of the device ( = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]).The common patient-related adverse events were retained foreign body ( = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse.
The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.
在临床试验中，通过细针活检设备进行内镜超声引导下组织采集的安全性已得到充分证实。但使用这些设备的实际经验尚不清楚。作者分析了美国食品药品监督管理局（FDA）制造商和用户设施设备经验（MAUDE）数据库的上市后监测数据来回答这个问题。
访问了2012年1月至2022年6月的FDA MAUDE数据库，以评估设备故障以及这些故障与患者相关的不良后果。
有344个与设备相关的问题。大多数问题是由于设备分离或破损（n = 185 [53.7%]）。其中76例破损（40.8%）发生在操作过程中，而89例（47.8%）发生在从内窥镜取出针时。针破损时最常见的组织活检部位是胰腺（44例 [23.8%]）。常见的与患者相关的不良事件是异物残留（n = 50 [14.5%]），其次是出血（16例，4.6%）。6例患者（3.4%）需要二次干预以取出残留异物，其中2例需要手术。设备破损导致3例（1.7%）内窥镜损坏，并有1例护士发生针刺伤。
细针活检设备可能会出现针破损和弯曲；这些不良事件此前未被报道。针破损可能会导致异物残留，这可能需要包括手术在内的额外操作。MAUDE数据库的这些实际发现可能为临床决策提供参考，并有助于改善临床结果。
