{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T08:04:50Z","timestamp":1784534690886,"version":"3.55.0"},"reference-count":18,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T00:00:00Z","timestamp":1779235200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Endourology"],"published-print":{"date-parts":[[2026,8,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Adverse events associated with flexible ureteroscopes are increasingly reported to postmarket surveillance systems; however, the lack of standardized harm classification limits reproducibility and actionable insights.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To develop and reliability-test a reproducible taxonomy for classifying patient harm and death in Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) reports (2020\u20132025) and to characterize mechanisms and severity profiles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      We conducted a retrospective cross-sectional analysis of 532 MAUDE reports (product class: ureteroscopes; event: injury\/death). Following the exclusion of nontarget devices (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 212), literature-only records (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 129), no-harm reports (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 5), and duplicates (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 39), 148 unique reports (including 1 death) were analyzed. Two independent clinicians coded reports using a prespecified taxonomy for (1) primary harm category, (2) harm mechanism, and (3) severity grade. Inter-rater reliability was quantified using unweighted and weighted Cohen\u2019s kappa (\u03ba).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Inter-rater reliability was substantial for the primary harm category (\u03ba = 0.82; 95% confidence interval [CI] 0.76\u20130.88; 86% agreement) and severity grade (weighted \u03ba = 0.79; 95% CI 0.71\u20130.87) but moderate for mechanism (\u03ba = 0.61). Traumatic (31.1%) and infectious (30.4%) categories predominated. Operational harm (clinical consequences without tissue injury) accounted for 20.3%. Most events (69.4%) were moderate or severe. While breakage\/detachment was the most common mechanism (27.0%), 48.0% of reports lacked sufficient detail for classification. Reports involving reprocessing\/contamination were disproportionately severe (63.6%). The single death involved septic shock with findings suggestive of device bioburden.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This reliability-tested taxonomy enables reproducible harm phenotyping in passive surveillance. However, nearly half of MAUDE narratives lack sufficient detail for mechanism coding. As a passive system lacking exposure denominators, MAUDE supports analysis of reporting composition but not incidence estimation or valid between-device comparisons.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/08927790261450702","type":"journal-article","created":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T10:43:37Z","timestamp":1779273817000},"page":"866-872","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient Harm Associated with Flexible Ureteroscopes: A Cross-Sectional Analysis of FDA MAUDE Reports with Reliability-Tested Harm Classification"],"prefix":"10.1177","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-4598-0652","authenticated-orcid":false,"given":"Dilmurat","family":"Akhmetov","sequence":"first","affiliation":[{"name":"Department of Urology and Kidney Transplantation, National Scientific Center of Surgery, Almaty, Kazakhstan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sayat S.","family":"Oraz","sequence":"additional","affiliation":[{"name":"Kazakh National Medical University, Almaty, Kazakhstan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dastan T.","family":"Kambarov","sequence":"additional","affiliation":[{"name":"Kazakh National Medical University, Almaty, Kazakhstan."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Bolatov","sequence":"additional","affiliation":[{"name":"Kazakh National Medical University, Almaty, Kazakhstan."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,5,20]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"European Association of Urology (EAU). EAU Guidelines on Urolithiasis (2025)."},{"key":"e_1_3_4_3_2","volume-title":"Surgical Management of Stones: American Urological Association\/Endourological Society Guideline","author":"Assimos D","unstructured":"Assimos D, et al. Surgical Management of Stones: American Urological Association\/Endourological Society Guideline. (Guideline PDF\/J Urol publication)."},{"key":"e_1_3_4_4_2","unstructured":"Somani BK et al. Complications associated with ureterorenoscopy (URS) for stone disease: Results from the CROES URS Global Study. (Large multicenter cohort\/complication profiling)."},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2023.03.029"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-019-03012-1"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1590\/s1677-5538.ibju.2021.0475"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1089\/end.2021.0006"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000108"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajic.2017.03.016"},{"key":"e_1_3_4_11_2","unstructured":"U.S. Food and Drug Administration (FDA). About Manufacturer and User Facility Device Experience (MAUDE) Database (incl. limitations of MDRs)."},{"key":"e_1_3_4_12_2","unstructured":"openFDA. Device adverse event (MDR)\/MAUDE data: Scope and limitations (passive surveillance; incidence\/prevalence not derivable)."},{"key":"e_1_3_4_13_2","unstructured":"Rajan PV et al. Medical Device Postapproval Safety Monitoring (discussion of passive surveillance\/denominator limitations)."},{"key":"e_1_3_4_14_2","unstructured":"World Health Organization (WHO). Conceptual Framework for the International Classification for Patient Safety (ICPS) Version 1.1 (Final Technical Report 2009)."},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1177\/001316446002000104"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1037\/h0026256"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-016-1909-0"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-024-05386-3"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajic.2017.03.016"}],"container-title":["Journal of Endourology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/08927790261450702","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/08927790261450702","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/08927790261450702","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T07:27:41Z","timestamp":1784532461000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/08927790261450702"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,20]]},"references-count":18,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8,1]]}},"alternative-id":["10.1177\/08927790261450702"],"URL":"https:\/\/doi.org\/10.1177\/08927790261450702","relation":{},"ISSN":["0892-7790","1557-900X"],"issn-type":[{"value":"0892-7790","type":"print"},{"value":"1557-900X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,20]]}}}