ROBOTIC SURGERY HAS BEEN LINKED TO INJURIES AND DEATHS; ALLEGED NEWS. [1] In 2015, it was reported that a study into the safety of surgical robots linked the machines' use to at least 144 deaths, and more than 1,000 injuries over a 14-year period in the United States of America; Alleged News. [1] The events included broken instruments falling into patients' bodies, electrical sparks causing tissue burns and system errors making surgery take longer than planned; Alleged News. [1] The study was carried out by researchers at the University of Illinois at Urbana-Champaign, the Massachusetts Institute of Technology and Chicago's Rush University Medical Center; Alleged News. [1]
Their paper said that 144 deaths, 1,391 injuries and 8,061 device malfunctions were recorded regarding robotic procedures carried out between January 2000 and December 2013; Alleged News. [1] This was based on reports submitted by hospitals, patients, device manufacturers and others to the US Food and Drug Administration, and the study noted that the true number could be higher; Alleged News. [1]
Also in 2015, it was reported by Doctors Health Press that robot-assisted surgery was linked to 10,000 injuries, malfunctions and deaths, according to FDA report; Alleged News. [2] The robots were involved in a number of patient injuries and deaths, according to a U.S. Food and Drug Administration (FDA) report, involving over 10,000 incidents; Alleged News. [2]
MAUDE database
The data was collected from the Manufacturer and User Facility Device Experience (MAUDE), a database where physicians, patients, and manufacturers report adverse events suspected to be caused by medical devices; Alleged News. [2]
The Doctors Health Press article noted as well, that surgical robots were reported as being involved in 144 deaths, 1,391 injuries and 8,061 device malfunctions that either extended the surgery, or forced it to be switched to a non-robotic procedure; Alleged News. [2] Due to changes in reporting practices and the fact that doctors, patients, and users may underreport, (it is only mandatory for manufacturers), these numbers were considered low-end estimations; Alleged News. [2]
Deaths, injuries, malfunctions
Among the deaths reported, 62% were attributed to to device malfunctions; Alleged News. [2] These malfunctions consisted of burnt or broken fragments of tools falling into the patient, electrical sparking or arcs, and the robot making an unexpected movement; Alleged News. [2] Similar rates were found for patient injuries in robotic procedures; Alleged News. [2]
Between 2007 and the time of the Doctors Health Press report in 2015, the annual rate of these injuries and deaths had been relatively constant; Alleged News. [2] Among specialties, gynaecology and urology procedures had the lowest rate of injury or death from the robotic procedures, and cardiothoracic or neck operations had the highest; Alleged News. [2]
In a study "Adverse events and device malfunctions in da Vinci robotic surgery: an analysis of MAUDE data from the recent decade" - published 10 December 2025 - Hsieh et.al. wrote that The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database provides a useful resource for characterizing malfunctions and safety outcomes across platforms; Alleged News. [3]
MAUDE reports
For purposes of the Hsieh et.al. study, MAUDE reports involving da Vinci surgical systems from January 2015 to January 2025 were reviewed; Alleged News. [3] Events were classified as malfunctions, injuries, or deaths, with malfunctions further characterized by type; Alleged News. [3] Conversions and procedure abortions were identified and analyzed; Alleged News. [3] The rates of adverse events were calculated and compared between robotic platforms; Alleged News. [3] Among da Vinci robotic surgeries performed during the study period, 66,651 MAUDE reports were identified; Alleged News. [3] There were 420.1 MAUDE reports, including 55.2 injuries, 3.1 deaths, 21.8 conversions, and 2.1 procedure abortion events, per 100,000 procedures; Alleged News. [3]
Compared with the da Vinci X/Xi, the da Vinci SP showed significantly higher risks of reported injury (RR29.9, P<0.001). death (RR 6.2, P< 0.001), conversion (RR9.4, P<0.001), and procedure abortion (RR16.1, P<0.001); Alleged News. [3]
Wrongful death lawsuit in Florida
A robotic device burned and tore a woman's small intestine while she was undergoing surgery for colon cancer, according to a wrongful death lawsuit filed during February, 2024, in Florida; Alleged News. [4] Mrs Sandra Sultzer developed abdominal pain and fever after her surgery in September 2021, and she needed additional procedures to close the tear, the lawsuit said; Alleged News. [4] The suit said she died in February 2022, because of the small intestine injury; Alleged News. [4] Her husband, Mr Harvey Sultzer, sued the maker of the device, Intuitive Surgical, for damages; Alleged News. [4]
The suit alleged that Intuitive Surgical knew the robot had insulation problems that might cause electricity to leak out, and burn internal organs, but did not disclose that risk to the Sultzers or the public; Alleged News. [4]
The suit further alleged that Intuitive had received thousands of reports about injuries and defects associated with the da Vinci; Alleged News. [4] A 2014 financial report that Intuitive filed with the Securities and Exchange commission said the company at the time, was a defendant in around 93 lawsuits; Alleged News. [4] The plaintiffs in about 93 lawsuits "allege that they or a family member underwent surgical procedures that utilized the da Vinci Surgical System, and sustained a variety of personal injuries, and, in some cases, death as a result of such surgery, " the company wrote; Alleged News. [4]
According to Sultzer's lawsuit, Intuitive received hundreds of complaints and reports about its da Vinci robot from July 2009 to December 2011; Alleged News. [4] Many of the reports mention cracks or slits on a rubber tip used to cover da Vinci's metal instruments, the suit said, adding that the defects allowed electricity to escape without surgeons' knowledge; Alleged News. [4]
In 2011, researchers from the University of Western Ontario flagged safety concerns with the device's surgical instruments in a study; Alleged News. [4] The researchers tested 37 instruments and found that all of them had "energy leakage", which in some cases they determined was sufficient to cause electrical burns; Alleged News. [4]
Study by Mendez-Probst et.al.
In the study "Stray electrical currents in laparascopic instruments used in da Vinci ® robot-assisted surgery: an in-vitro study," Mendez-Probst et al., stated as abstract the following four;
1. Background and purpose, 2. materials and methods, 3. results, 4. conclusions. [5]
"Background and purpose: The da Vinci (®) surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure. We" (Mendez-Probst et al). "used objective measures to report the prevalence and magnitude of such stray currents"; Alleged News. [5]
"Materials and methods: Thirty-seven robotic instruments were tested using an electrosurgical unit (ESU) at pure coagulation and cut waveforms at four different settings. Conductive gel-coated instruments were tested at 40W, 80W, and maximum ESU output (coagulation 120W, cut 300W). The magnitude of stray currents was measured by an electrosurgical analyzer"; Alleged News. [5]
"Results: At coagulation waveform in open air, 86% of instruments leaked a mean of 0.4W. In the presence of gel-coated instruments, stray currents were detected in all instruments with means (and standard deviation) of 3.4W (± 2), 4.1W (± 2.3), and 4.1W (± 2.3), at 40W, 80W, and 120 W, respectively. At cut waveform in open air, none of the instruments leaked current, while gel-coated instruments leaked a mean of 2.2W (± 1.3), 2.2W (± 1.9) and 3.2W (± 1.9) at 40W, 80W, and 300W, respectively"; Alleged News. [5]
The conclusions of Mendez-Probst et.al., were as follows; "All tested instruments in our study demonstrated energy leakage. Stray currents were higher during coagulation (high voltage) waveforms, and the magnitude was not always proportionate to the ESU settings. Stray currents have the potential to cause electrical burns. We support the programmed end of life of da Vinci instruments on the basis of safety. Consideration should be given to alternate energy sources or the adoption of active electrode monitoring technology to all monopolar instruments," Alleged News. [5]
Burns, injuries, damaged colon, burned uterus
A 2018 NBC News analysis identified more than 20,000 adverse events related to the da Vinci in the 10 years prior to 2018, based on reports filed to the FDA's MAUDE database; Alleged News. [4] Most of the reports were related to malfunctions, some of which were minor; Alleged News. [4] 2,000 reports cited injuries, and 274 involved deaths; Alleged News. [4]
In total, more than a dozen patients told NBC News in 2018, that they were burned or injured during procedures that involved the da Vinci; Alleged News. [4] One woman's medical records showed that her colon was damaged, and that her uterus was burned during a 2015 hysterectomy involving the robot; Alleged News. [4]
[1] BBC News. Robotic surgery linked to 144 deaths in the US: Alleged News
https://www.bbc.com/news/technology-33609495
[2]Newman, Adrian, B.A. Doctor Health Express. Robot-Assisted Surgery linked to 10,000 injuries, malfunctions, and deaths; FDA reports; Alleged News
https://www.doctorshealthpress.com/robot-assisted-surgery-linked-to-10000-injuries-malfunctions-and-deaths-fda-reports/
[3] Journal of Robotic Surgery. Hsieh, Tsung-Yi et.al. Adverse events and device malfunctions in da Vinci robotic surgery: an analysis of MAUDE data from the recent decade; Alleged News
https://link.springer.com/article/10.1007/s11701-025-02947-5
[4] Robotic device burned a woman's small intestine during surgery, lawsuit alleges; Alleged News
https://www.nbcnews.com/health/health-news/robotic-device-burned-womans-small-intestine-surgery-lawsuit-alleges-rcna137998
[5] National Library of Medicine. Mendez-Probst, et.al. "Stray electrical currents in laparascopic instruments used in da Vinci ® robot-assisted surgery: an in-vitro study," Alleged News
https://pubmed.ncbi.nlm.nih.gov/21815828/
With thanks to bbc.com, doctorshealthpress.com, link.springer.com, nbcnews.com and pubmed.ncbi.nlm.nih.gov
Image courtesy of ChatGPT with CN Whittle
