Laparoscopic and Robotic Device Malfunction: A Scoping Review

Laparoscopic and robotic surgeries have become the gold standard for many operations. Device malfunctions during these procedures represent a preventable source of patient harm; however, the trends in malfunction reporting and their implications for surveillance systems, surgical training, and reporting infrastructure have not been comprehensively reviewed. Our aim is to conduct a scoping review of device malfunctions during minimally invasive abdominopelvic surgeries. Four databases (Web of Science, Scopus, Embase, and PubMed) were searched for relevant articles published between January 1, 1974, and March, 15, 2024. Studies analyzing the Manufacturer and User Facility Device Experience (MAUDE) database for device malfunctions involving staplers or energy-based devices in laparoscopic and robotic abdominopelvic surgeries were included. Reviews, case series, animal studies, and investigations of user error or implanted device failures were excluded. Two independent reviewers screened each article. Of 770 identified articles, 15 met the inclusion criteria. Nine focused on robotic surgical instruments (7 on the da Vinci Surgical System), 5 on laparoscopic staplers (4 nephrectomy-related), and 1 on staplers across specialties. Death was the least common outcome, followed by injuries and malfunctions without patient harm. In laparoscopic nephrectomy, stapler misfiring caused 22 deaths (5.7% of complications). Robotic surgery deaths ranged from 1.2% to 2.3%, depending on the study. This first comprehensive synthesis of MAUDE-based analyses in minimally invasive surgery reveals substantial variability in reporting practices and highlights system-level gaps in surveillance, staff training, and accountability. Standardized, multicenter reporting frameworks are needed to accurately characterize the risk of malfunction and support targeted preventive interventions.