Medicolegal aspects of robotic-assisted surgery: litigation trends, complication risks, and human factors interventions.

چکیده اصلی

Robotic-assisted surgery (RAS) sees over six million procedures performed annually. Malpractice claims involving RAS increased by more than 250% between the periods 2006-2013 and 2014-2021 [1]. Understanding the legal landscape, risk profile, and evidence-based mitigation strategies is critical for all stakeholders. This scoping review aimed to: (1) map medicolegal cases involving RAS; (2) quantify complication incidence (3) characterise general and procedure-specific risks; and (4) synthesise interventions capable of reducing adverse events and litigation exposure. A structured search of PubMed/MEDLINE, EMBASE, the Westlaw legal database and FDA MAUDE was conducted for English-language sources from January 2000 to May 2026 [2]. Included sources reported medicolegal cases, adverse event rates, or human factors interventions in RAS. Sixty-one US malpractice cases were identified with 169 total liabilities claimed, most commonly negligent surgery, misdiagnosis, delayed treatment, and lack of informed consent [1]. Individual indemnity payments averaged $1,251,274. FDA MAUDE data (2000-2013) recorded 144 deaths, 1,391 injuries, and 8,061 device malfunctions across 1.75 million procedures [3]. Overall adverse event rates were 0.0834% [3]. Key modifiable risk factors include cognitive overload, loss of haptic feedback, team communication breakdown, and suboptimal ergonomics [4-7]. Medicolegal risk in RAS is rising but remains concentrated in a small number of procedure types and surgeon-experience brackets. The majority of claims relate to human error rather than device malfunction [1]. Severable actionable risk-reduction strategies such as structured training, governance, simulation-based competency are discussed [6, 8-10]. Adverse event registries and credentialing standards remain urgent legislative priorities.

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