{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T17:11:00Z","timestamp":1775668260631,"version":"3.50.1"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T00:00:00Z","timestamp":1675123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["World j. otorhinolaryngol.-head neck surg."],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Functional endoscopic sinus surgery\u00a0is a commonly performed otolaryngologic procedure that often uses the microdebrider device for tissue removal. Given the ubiquitous nature of the instrument, we sought to better define the patterns of device failure using the postmarket surveillance openFDA database.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The openFDA database was queried for all microdebrider\u2010related adverse events from January 1,\u00a02000 to November 1,\u00a02020. Descriptive information on the nature of device failure and any associated patient injury was compiled. Reports not directly related to device failure were excluded from the analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 641 events were included in the analysis. The most common device failure was overheating (<jats:italic>n<\/jats:italic>\u2009=\u2009348, 54.3%), followed by material separation (<jats:italic>n<\/jats:italic>\u2009=\u2009173, 27%), and inconsistent device activation (<jats:italic>n<\/jats:italic>\u2009=\u200952, 8.1%). Of the reported events, the vast majority did not result in patient harm (<jats:italic>n<\/jats:italic>\u2009=\u2009579, 90.3%). On review of the remaining cases, only 24 events (3.7%) resulted in true harm to the patient, defined as a temporary or permanent injury or &gt;30\u2009min of additional anesthesia time. Of these cases, the need to reschedule surgical cases (<jats:italic>n<\/jats:italic>\u2009=\u20095, 0.8%), retained foreign body (<jats:italic>n<\/jats:italic>\u2009=\u20095, 0.8%), and thermal tissue injury (<jats:italic>n<\/jats:italic>\u2009=\u20093,0.5%) were the most common. Five patients suffered an injury due to surgeon error unrelated to device malfunction (<jats:italic>n<\/jats:italic>\u2009=\u20095, 0.8%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Microdebrider device failures are extremely rare. When they do occur, less than 10% result in patient harm. In cases of patient harm related to microdebrider failure, preoperative testing of the device before use could prevent many of the reported malfunctions.<\/jats:p><\/jats:sec>","DOI":"10.1002\/wjo2.89","type":"journal-article","created":{"date-parts":[[2023,2,1]],"date-time":"2023-02-01T07:06:30Z","timestamp":1675235190000},"page":"328-332","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Microdebrider complications in sinus surgery: Analysis of the openFDA database"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6186-9912","authenticated-orcid":false,"given":"Elias S.","family":"Saba","sequence":"first","affiliation":[{"name":"Department of Head and Neck Surgery Kaiser Permanente Oakland Medical Center Oakland California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob","family":"Hoerter","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Kaiser Permanente Oakland Medical Center Oakland California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeremy","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology\u2010Head and Neck Surgery, Perelman School of Medicine University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David W.","family":"Chou","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery Mount Sinai Medical Center New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Xiao","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Kaiser Permanente Oakland Medical Center Oakland California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacob G.","family":"Eide","sequence":"additional","affiliation":[{"name":"Department 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