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Procedural sedation and analgesia (PSA) is generally considered safe, yet fatal events remain poorly characterised across procedures and specialties. We retrospectively reviewed the Japan Council for Quality Health Care nationwide adverse-event database (2012–2021), searching narrative reports with 40 Japanese keywords for sedation terms and drug names. Only reports in which PSA was deemed the primary cause of death were included; non-procedural sedation, planned general anaesthesia and procedure-induced injuries were excluded. Among 10 011 reports identified via keyword search, 805 described deaths and 23 were attributed to PSA. Fatalities clustered in gastroenterology (73.9%), particularly endoscopic retrograde cholangiopancreatography (ERCP; 34.8%). Most cases were high-risk patients aged 70–89 years (65.2%) and retrospectively classified as American Society of Anesthesiologists Physical Status III/IV (87%), yet no anaesthetist involvement was documented. Oxygen desaturation was the earliest sign of deterioration (56.5%), and capnography was not documented in any case. When PSA fatalities in Japan are examined across procedures and specialties, gastrointestinal interventions—especially ERCP—predominate in our cohort; however, the absence of procedure-specific denominators warrants cautious interpretation. Targeted safety measures, in line with current national sedation guidelines, including enhanced presedation evaluation, anaesthetist involvement for high-risk patients and routine capnography, may help to reduce PSA-related mortality.