Reported device problems and patient outcomes in da Vinci robotic robotic gastric and upper-gastrointestinal procedures: an FDA MAUDE database analysis.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος:	Reported device problems and patient outcomes in da Vinci robotic robotic gastric and upper-gastrointestinal procedures: an FDA MAUDE database analysis.
Συγγραφείς:	Song P; Gastrointestinal Surgery Ward 1, Shengli Oilfield Central Hospital, Dongying, China., Sun D; Gastrointestinal Surgery Ward 1, Shengli Oilfield Central Hospital, Dongying, China. jasonsdw@163.com.
Πηγή:	Journal of robotic surgery [J Robot Surg] 2026 Sep 02; Vol. 20 (1). Date of Electronic Publication: 2026 Sep 02.
Τύπος έκδοσης:	Journal Article
Γλώσσα:	English
Στοιχεία περιοδικού:	Publisher: Springer Country of Publication: England NLM ID: 101300401 Publication Model: Electronic Cited Medium: Internet ISSN: 1863-2491 (Electronic) Linking ISSN: 18632483 NLM ISO Abbreviation: J Robot Surg Subsets: MEDLINE
Imprint Name(s):	Original Publication: London : Springer
Ιατρικοί όροι (MeSH):	Robotic Surgical Procedures/instrumentation , Robotic Surgical Procedures/methods , Equipment Failure/statistics & numerical data , Gastrectomy/instrumentation , Gastrectomy/methods , Digestive System Surgical Procedures/instrumentation , Digestive System Surgical Procedures/methods , Product Surveillance, Postmarketing, Humans ; United States ; United States Food and Drug Administration ; Databases, Factual ; Retrospective Studies ; Treatment Outcome
Περίληψη:	Robotic gastric and upper-gastrointestinal procedures include bariatric/metabolic operations, conventional/oncologic gastrectomy, and other procedures. Postmarket surveillance of reported device problems in this heterogeneous setting remains limited. To describe reported device problems and patient outcomes in robotic gastric and upper-gastrointestinal procedures using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. We conducted a retrospective analysis of MAUDE reports from 2009 to 2025. Procedures were categorized as bariatric/metabolic, conventional/oncologic gastrectomy, or other/unspecified gastric or upper-gastrointestinal procedures. Device-problem descriptors, report characteristics, and report-level outcome associations were analyzed. Among 1,073 analyzed reports, device-problem descriptor profiles varied across reported platform categories. The da Vinci Xi category frequently included software or display descriptors, whereas the da Vinci Standard / Unspecified category frequently included stapling-related descriptors. In a procedure-adjusted multivariable model, Firing Problem (OR 9.53, 95% Wald CI 4.36-20.82), Misfire (OR 17.91, 95% Wald CI 7.10-45.21), and Failure to Form Staple (OR 17.59, 95% Wald CI 8.72-35.48) were associated with the selected severe-outcome indicator. Documentation/reporting factors were analyzed separately and were not interpreted as confirmed device malfunctions. This report-level analysis describes patterns of submitted device-problem descriptors and selected patient-outcome flags in robotic gastric and upper-gastrointestinal procedures. These associations are hypothesis-generating and do not establish device root cause, malfunction incidence, comparative safety, clinical effectiveness, or causal risk. Prospective, procedure-specific surveillance with standardized outcome adjudication and procedure-volume denominators is needed to evaluate device performance and clinical outcomes. (© 2026. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)
Competing Interests:	Declarations. Conflict of interest: The authors declare no competing interests. Ethical Approval: The U.S. FDA MAUDE database, a publicly available repository with de-identified reports of adverse events involving medical devices submitted by manufacturers, healthcare providers, and consumers, provided the data used in this study. Consent for publication: Not applicable.
References:	Obes Surg. 2024 Sep;34(9):3493-3505. (PMID: 39042305) J Endourol. 2019 Aug;33(8):649-654. (PMID: 31037961) Crit Rev Oncol Hematol. 2023 Jan;181:103841. (PMID: 36240980) Gastroenterology. 2023 Dec;165(6):1352-1366.e1. (PMID: 37652306) Obes Surg. 2023 Jan;33(1):3-14. (PMID: 36336720) Eur J Surg Oncol. 2026 Jul;52(7):111865. (PMID: 42127609) Clin Otolaryngol. 2018 Apr;43(2):638-644. (PMID: 29194991) Ann Surg. 2023 Nov 1;278(5):e932-e938. (PMID: 36692109) Surg Endosc. 2025 Sep;39(9):6132-6138. (PMID: 40681650) Sci Rep. 2022 Nov 29;12(1):20566. (PMID: 36446802) Obes Surg. 2025 Jun;35(6):2191-2201. (PMID: 40332741) Ann Surg Oncol. 2025 Jan;32(1):351-373. (PMID: 39419891) Surg Endosc. 2022 Jun;36(6):4171-4180. (PMID: 34622300) JAMA. 2019 May 28;321(20):1983-1992. (PMID: 31135850) Actas Urol Esp (Engl Ed). 2018 Mar;42(2):77-85. (PMID: 28478913) Obes Surg. 2026 Mar;36(3):1370-1376. (PMID: 41708973) Surg Endosc. 2021 May;35(5):1976-1989. (PMID: 33398585) Front Med (Lausanne). 2025 Sep 17;12:1634451. (PMID: 41041446) Tech Coloproctol. 2024 Nov 10;28(1):152. (PMID: 39522086) Clin Obstet Gynecol. 2008 Mar;51(1):120-3. (PMID: 18303506) J Laparoendosc Adv Surg Tech A. 2019 Feb;29(2):147-151. (PMID: 30222522) J Robot Surg. 2025 Dec 10;20(1):72. (PMID: 41366578) J Robot Surg. 2024 Nov 7;18(1):398. (PMID: 39508908) Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1155-1165. (PMID: 31318470) J Robot Surg. 2025 Jun 28;19(1):332. (PMID: 40580391) World J Surg Oncol. 2025 Oct 31;23(1):412. (PMID: 41174649)
Contributed Indexing:	Keywords: Da Vinci; Device malfunction; MAUDE database; Patient safety; Postmarket surveillance; Robotic-assisted gastrectomy; Surgical staplers
Entry Date(s):	Date Created: 20260902 Date Completed: 20260902 Latest Revision: 20261008
Update Code:	20261008
DOI:	10.1007/s11701-026-03897-2
PMID:	42684551
Βάση Δεδομένων:	MEDLINE

Περιγραφή
ISSN:	1863-2491
DOI:	10.1007/s11701-026-03897-2