Robotic-assisted surgery (RAS) emerged in the early 21st century and has been widely adopted by hospitals in the United States, serving as an alternative minimally invasive surgical technique to traditional laparoscopic techniques. The da Vinci surgical system, the only clinical robotic surgical system approved by the FDA for general laparoscopic surgery, consists of a camera arm and three mechanical arms with surgical instruments attached to them. RAS is performed using small incisions, often reducing post operative recovery time, hospital stay, and discomfort for patients.
It allows surgeons to perform complex surgical procedures with more precision and flexibility than possible with conventional techniques. Despite these benefits, Intuitive Surgical, the company that created the da Vinci surgical system, proclaims that they are facing a number of product liability claims and 52 lawsuits alleging their machines are responsible for patient injury (Baron, 2017, p.1).
The number of product liability claims and lawsuits against RAS technology indicates that there are limitations in its ability to effectively perform surgical procedures.
Limitations in this groundbreaking surgical technique, such as technological malfunctions and reduced tactile perception, have been identified by biomedical researchers and the FDA, making RAS a less viable alternative. Although surgeons performing RAS claim that robotic technology provides them with enhanced dexterity, the limitations in the abilities of robotic-assisted surgery is causing complications during surgical procedures.
Some surgeons that perform RAS claim that it allows them to execute various complex procedures with increased precision, proficiency, and ergonomics. One of the many advantages of RAS is discussed in a peer-reviewed article that examines the positive impacts of RAS on pancreatic resection and reconstruction.
These researchers assert that RAS technology addresses the shortcomings of traditional surgery; its specialized three-axis motion of surgical instruments provides greater mobility, greatly improving surgeon comfort (Zuriekat et al., 2011). This suggests that the increased mobility of the robotic arms and surgical instruments potentially prevents surgeons from maintaining an uncomfortable posture while performing a procedure. Surgeons must simply control these instruments seated at a console, which helps relieve the discomfort they face while performing traditional surgery. They do not have to stand throughout the surgery, which reduces surgeon fatigue and discomfort, keeping the surgeon more relaxed and mentally sharp throughout the procedure.
Additionally, features such as enhanced visualization are possible due to a 3D camera on one of the 3 robotic arms, permitting surgeons to perform small, accurate dissection and suturing. However, a peer-reviewed study conducted on the effectiveness of RAS in oncology, revealed that these benefits can only be gained through thorough additional training and an increased caseload of surgeries performed with robotic technology (Rocco, Albo, & Gaia, n.d.). If the surgeon is not well-trained on operating this complex technology they may not be equipped to resolve any technology issues that may arise. However, many surgeons are not receiving proper training in performing RAS procedures due to the increased expenses it imposes on hospitals and medical schools. Inexperienced surgeons operating with robotic technology often results in failed surgeries. In addition to inadequate training, the unreliability of robotic technology may also play a role in complicating RAS procedures.
In contrast to surgeons that advocate for the increased ergonomics of robotic-assisted surgery, biomedical researchers have found that these benefits are potentially compromised due to mechanical failures, making RAS unreliable. For instance, a peer-reviewed study conducted by Finan and Rocconi (2010) investigated 137 RAS cases, finding that “8.02% of these cases were associated with problems such as malfunction of robotic arms, surgical instruments, and light cords” (p. 1). These technological problems increase the time taken to perform the procedure by requiring the surgeon to troubleshoot the technology, consequently interrupting the operation. Interruption of the operation can have detrimental effects on patients such as infection or blood loss, resulting in the failure of the surgical procedure. Device malfunction could result in the surgeon losing control of the device and vision of the surgical site, leading to malpractice by the surgeon, ultimately causing harm to the patient.
Moreover, a peer-reviewed journal article written by a group of surgeons and medical researchers, revealed that a major limitation for surgeons is the lack of tactile information felt while performing RAS (Randell et al., 2015). Surgeons control the surgical instruments and robotic arms at a console while viewing the surgical site through a camera, so they are physically unable to feel the surgical site. Lack of tactile information could cause surgeons to be hesitant and perform the surgery more slowly because they are only able to rely on visual information. Surgeons could also misjudge the surgical site and make inaccurate incisions, potentially complicating the surgical procedure.
Biomedical researchers have also begun to form a strong alliance with the FDA regarding their opinion on the uncertainty of robotic technology, as both groups share common concerns on its reliability and potential negative effects on a surgical procedure. In a government article on the U.S Food and Drug Administration website about Robotic-Assisted Surgical Systems, the FDA states they are “aware of an increase in the number of medical device reports related to robotically-assisted surgical devices [and a] majority of the medical device reports the FDA received were of device malfunctions, such as component breakage, mechanical problems and image/display issues” (U.S Food and Drug Administration, 2018, p. 1). An increase in medical device reports due to device malfunction indicates that RAS technology is unpredictable and can often malfunction during surgical procedures.
The fact that the FDA is still identifying potential device-related safety issues in the RAS devices, shows that there is still great room for technological improvement and re-evaluation of robotic surgical devices, implying that RAS is not yet a practical surgical option. In a Wall Street journal article evaluating the pros and cons of robotic surgery, reports cited in the article by medical researchers and physicians at Rush University Medical Center, University of Illinois, and MIT revealed that the FDA had received reports of a 34% increase in injury and death reports due to unresolved safety issues in the da Vinci surgical system (Pinkerton, 2013, p. 2). Additionally, an analysis of RAS related reports from 14 years of FDA data was conducted in a peer-reviewed article and it was found that 8,061 RAS device malfunctions were reported (Alemzadeh et al., 2016).
These statistics show that the large number of instrument malfunctions, comprising of issues such as system errors, imaging problems, and unintended instrument operation, resulted in an increased number of death and injury reports-stipulating that robotic technology is not completely reliable. Lack of testing and troubleshooting of the robotic technology is evident in the large number of negatively affected surgical procedures, device malfunctions, and death and injury reports of patients. Adoption of more advanced robotic techniques is vital towards increasing the safety and reliability of RAS, so that surgical procedures are not put at risk.
With RAS growing in popularity among surgeons throughout the United States, the number of RAS procedures performed annually is on the rise. Due to the increase in RAS conducted procedures, device malfunction reports, patient injury, and death rates have substantially increased. Limitations in robotic technology such as device malfunction and reduction of tactile perception are a major cause of negative effects robotic technology has on surgical procedures and patients; however, these risks can be avoided. Due to the intricacy and complexity of robotic technology, surgeons must undergo increased training and meet higher qualifications to perform RAS procedures. To be more effective, a larger number of medical schools must adopt RAS training programs. Surgeons and hospitals with RAS facilities must become more aware of the potential risk robotic technology poses on the surgical procedure and require their surgeons to undergo proper training to make robotic-assisted surgery a more viable surgical technique.