{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T10:49:26Z","timestamp":1784198966885,"version":"3.55.0"},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2023,8,12]],"date-time":"2023-08-12T00:00:00Z","timestamp":1691798400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-sa\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Endosc Ultrasound"],"published-print":{"date-parts":[[2023,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n The safety of endoscopic ultrasound\u2013guided 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n<\/jats:italic> = 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%]).<\/jats:p>\n The common patient-related adverse events were retained foreign body (n<\/jats:italic> = 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.1097\/eus.0000000000000016","type":"journal-article","created":{"date-parts":[[2023,10,31]],"date-time":"2023-10-31T09:00:09Z","timestamp":1698742809000},"page":"424-427","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":3,"title":["Device malfunctions with use of EUS\u2013guided fine-needle biopsy devices: Analysis of the MAUDE database"],"prefix":"10.1097","volume":"12","author":[{"given":"Achintya D.","family":"Singh","sequence":"first","affiliation":[{"name":"Gastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepak","family":"Madhu","sequence":"additional","affiliation":[{"name":"Gastroenterology, Lisie Institute of Gastroenterology, Lisie Hospital, Kochi, Ernakulam, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mythili Menon","family":"Pathiyil","sequence":"additional","affiliation":[{"name":"Internal Medicine, Saint Vincent Hospital, Worcester, MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daryl","family":"Ramai","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology, University of Utah Health, Salt Lake City, UT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babu P.","family":"Mohan","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology, University of Utah Health, Salt Lake City, UT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhavesh","family":"Shah","sequence":"additional","affiliation":[{"name":"Gastroenterology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas G.","family":"Adler","sequence":"additional","affiliation":[{"name":"Gastroenterology, Center for Advanced Therapeutic Endoscopy, Denver, CO, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2023,8,12]]},"reference":[{"issue":"5","key":"bib1-20250826","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1016\/j.jasc.2020.05.006","article-title":"Current status of newer generation endoscopic ultrasound core needles in the diagnostic evaluation of gastrointestinal lesions","volume":"9","year":"2020","journal-title":"J Am Soc Cytopathol"},{"issue":"1","key":"bib2-20250826","doi-asserted-by":"crossref","first-page":"e000408","DOI":"10.1136\/bmjgast-2020-000408","article-title":"Endoscopic ultrasound (EUS) and the management of pancreatic cancer","volume":"7","year":"2020","journal-title":"BMJ Open Gastroenterol"},{"issue":"4","key":"bib3-20250826","doi-asserted-by":"crossref","first-page":"225","DOI":"10.4103\/eus.eus_21_20","article-title":"EUS tissue acquisition: from A to B","volume":"9","year":"2020","journal-title":"Endosc Ultrasound"},{"issue":"6","key":"bib4-20250826","doi-asserted-by":"crossref","first-page":"E853","DOI":"10.1055\/a-1381-7301","article-title":"Comparative diagnostic accuracy of EUS needles in solid pancreatic masses: a network meta-analysis","volume":"9","year":"2021","journal-title":"Endosc Int Open"},{"issue":"5","key":"bib5-20250826","doi-asserted-by":"crossref","first-page":"E363","DOI":"10.1055\/s-0043-101693","article-title":"A meta-analysis of endoscopic ultrasound-fine-needle aspiration compared to endoscopic ultrasound-fine-needle biopsy: diagnostic yield and the value of onsite cytopathological assessment","volume":"5","year":"2017","journal-title":"Endosc Int Open"},{"issue":"6","key":"bib6-20250826","doi-asserted-by":"crossref","first-page":"382","DOI":"10.4103\/eus.eus_27_19","article-title":"Comparison of Franseen and fork-tip needles for EUS-guided fine-needle biopsy of solid mass lesions: a systematic review and meta-analysis","volume":"8","year":"2019","journal-title":"Endosc Ultrasound"},{"issue":"8","key":"bib7-20250826","doi-asserted-by":"crossref","first-page":"454","DOI":"10.4253\/wjge.v11.i8.454","article-title":"Endoscopic ultrasound-guided sampling of solid pancreatic masses: the fine needle aspiration or fine needle biopsy dilemma. 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