J Robot Surg. 2026 Jun 3;20(1):575. doi: 10.1007/s11701-026-03537-9.
ABSTRACT
Robotic-assisted hysterectomy is widely performed, yet device-related malfunctions and their impact on patient safety remain incompletely characterized. This study evaluates device-specific malfunctions and associated patient harm across Da Vinci system generations using the FDA MAUDE database. A retrospective descriptive analysis of adverse event reports submitted to the MAUDE database from system approval dates through March 19, 2026, was conducted. Reports involving robotic-assisted hysterectomy using Da Vinci Si, Xi, SP, and 5 systems were included. Device and patient problems were summarized using frequencies and percentages. Co-occurrence network analysis identified commonly associated device problems. A major limitation of the MAUDE database is the lack of data on the total number of surgeries. Each system, including Xi, SP, and Si, had different deployment periods and operational volumes. Direct comparisons of malfunction numbers and rates between systems lack statistical validity. Such comparisons should be avoided or, if possible, adjusted using the number of operational units and the time they have been on the market. Among 11,190 retrieved reports, 1,278 involved hysterectomy. After excluding 28 reports with “Insufficient Information,” 1,250 reports were analyzed. The Xi system (n = 370 device problems) most frequently reported “Visual Prompts will not Clear” (29.2%), with hemorrhage (20.5%) as the leading patient problem; no deaths were reported in the revised Xi dataset. The SP system (n = 12 device problems) most frequently reported “Visual Prompts will not Clear” (33.3%), with unspecified tissue injury (37.5%) as the leading patient problem. The Si system (n = 71 device problems) most frequently reported “Device Displays Incorrect Message” (32.4%), with strong co-occurrence between incorrect messaging and unexpected device behavior (weight = 11); bowel perforation and fistula each accounted for 16.7% of patient problems, and one death (8.3%) was documented. The Da Vinci 5 system (n = 2 reports) reported a pressure problem with no associated patient adverse events. Because the MAUDE database does not provide the total number of hysterectomies performed with each system, the number of active systems per year, or system-specific procedure volumes, raw malfunction frequencies cannot be used to compare failure rates across the Xi, SP, Si, or 5 platforms. Accordingly, the following results are presented as descriptive summaries only, without cross-system rate comparisons. Device malfunctions in robotic hysterectomy vary by Da Vinci model, predominantly involve software-interface issues such as persistent visual prompts and incorrect messaging, and are associated with serious patient harm including hemorrhage, bowel perforation, fistula, and death. The absence of mortality in the revised Xi dataset and the limited data from the Da Vinci 5 system highlight the need for continued postmarket surveillance. These findings underscore the importance of improved system design, standardized reporting, and enhanced adverse event documentation to better characterize device-related risks in robotic-assisted hysterectomy.
PMID:42231012 | DOI:10.1007/s11701-026-03537-9
