Reliability of robotic system during general surgical procedures in a university hospital

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1 The American Journal of Surgery (2014) 207, Clinical Science Reliability of robotic system during general surgical procedures in a university hospital Nicolas C. Buchs, M.D.*, François Pugin, M.D., Francesco Volonté, M.D., Philippe Morel, M.D. Clinic for Visceral and Transplantation Surgery, Department of Surgery, University Hospital of Geneva, Rue Gabriel- Perret-Gentil, 4, 1211 Geneva 14, Switzerland KEYWORDS: Robot; da Vinci Surgical System; Reliability; Safety; Failure; General surgery Abstract BACKGROUND: Data concerning the reliability of robotic systems are scarce, especially for general surgery. The aim of this study was to assess the incidence and consequences of robotic malfunction in a teaching institution. METHODS: From January 2006 to September 2012, 526 consecutive robotic general surgical procedures were performed. All failures were prospectively recorded in a computerized database and reviewed retrospectively. RESULTS: Robotic malfunctions occurred in 18 cases (3.4%). These dysfunctions concerned the robotic instruments in 9 cases, the robotic arms in 4 cases, the surgical console in 3 cases, and the optical system in 2 cases. Two malfunctions were considered critical, and 1 led to a laparoscopic conversion (conversion rate due to malfunction,.2%). Overall, there were more dysfunctions at the beginning of the study period (2006 to 2010) than more recently (2011 to 2012) (4.2% vs 2.6%, P 5.35). CONCLUSIONS: The robotic system malfunction rate was low. Most malfunctions could be resolved during surgery, allowing the procedures to be completed safely. With increased experience, the system malfunction rate seems to be reduced. Ó 2014 Elsevier Inc. All rights reserved. Since the introduction of robotics for general surgery, many reports have shown not only the feasibility but also the safety of this approach, even in advanced cases. 1,2 Pancreatic and liver resections, for example, have been performed with encouraging results using a robotic approach, 3 6 although they are considered to be rather demanding laparoscopic procedures. In terms of safety, no specific risk factors for morbidity after robotic general surgery have been reported, Drs Buchs and Pugin contributed equally to this work. The authors declare no conflicts of interest. * Corresponding author. Tel.: ; fax: address: nicolas.c.buchs@hcuge.ch Manuscript received February 27, 2013; revised manuscript June 10, 2013 with the exception of a multiquadrant approach. 2 Otherwise, the risk factors for complications are similar to those already reported for open or laparoscopic surgery. 2,7 Clearly, this new technology has significant advantages, such as 3-dimensional vision, tremor filtration, stability, and increased maneuverability, that can overcome the technical limitations of standard laparoscopy. However, the potential technical advantages of the robotic approach are delivered through sophisticated engineering that is significantly more complex in both hardware and software than laparoscopic instruments. Additionally, the da Vinci Surgical System (Intuitive Surgical Inc, Sunnyvale, CA) is an entire system solution for surgery instead of a set of instruments. Therefore, by its nature, the robotic system might be more prone to dysfunction than a simpler surgical solution. Additionally, /$ - see front matter Ó 2014 Elsevier Inc. All rights reserved.

2 N.C. Buchs et al. Reliability of da Vinci system during general surgery 85 for the first time, the operating surgeon is not at the patient s side during a robotic procedure. Thus, he or she needs to trust the robotic system, the assistant surgeon, and the scrub team. Several centers have evaluated the risk for malfunction of the system, especially for urology, 8 13 gynecology, 14 and pediatric surgery, 15 but for general surgery, the data remain relatively scarce. 16,17 Some groups have reported interesting results, with malfunction rates ranging from 2.4 to 4.5%. 10,18 As a teaching institution, we started our robotic program in 2006 and were immediately concerned with the safety of the system. The aim of this study was thus to assess the incidence and consequences of robotic malfunction. Methods From January 2006 to September 2012, 526 consecutive robotic general surgical procedures were prospectively recorded and constitute our study population. The different surgical procedures are summarized in Table 1. During the study period, 3 different robotic systems were used consecutively. The first da Vinci Surgical System was introduced in January It was the first version of the system. Then in May 2008, the system was upgraded to the da Vinci S System, and finally, in April 2010, the last version, the da Vinci Si System, was acquired as well. Actually, 2 different systems (the S and Si) are currently used and shared at our hospital in a multidisciplinary program All procedures were performed by various experienced surgeons. The same dedicated scrub nurses were in charge Table 1 Types of robotic general surgical procedures Procedure n Bariatric surgery 327 Roux-en-Y gastric bypass 320 Sleeve gastrectomy 6 Removal of gastric banding 1 Upper gastrointestinal surgery 50 Nissen fundoplication 40 Heller myotomy 3 Partial gastrectomy 7 Colorectal surgery 40 Right colectomy 7 Sigmoidectomy 14 Low anterior resection 8 Abdominoperineal amputation 2 Rectopexy 7 Transanal endoscopic microsurgery 2 Hepatobiliary and pancreatic surgery 107 Cholecystectomy* 97 Minor hepatectomy 9 Distal pancreatectomy 1 Others 2 Total 526 *Including 75 single-site cholecystectomies. of the draping and setup of the robot as well as intraoperative assistance during the procedure. A system failure was defined as any deviation from the standard and normal course of the robotic procedure and due to the system itself. All these failures were prospectively recorded in a computerized database and reviewed retrospectively. The type of malfunction, the consequences, and how it was managed were recorded as well. Robotic malfunctions were categorized as related to robotic arms, robotic instruments, optical or video systems, or the surgical console. Instrument malfunctions were subclassified according to the type of instrument. Statistical analysis The results of parametric and nonparametric data analysis are expressed as mean 6 SD and median (range), respectively. GraphPad (GraphPad Software, La Jolla CA) was used for all statistical analyses. Confidence intervals were set at 95%. Two-sided P values %.05 were considered statistically significant. Comparisons between both groups were determined using Fisher s exact test for discrete variables and Student s t test for continuous variables. Results During the study period, a total of 526 robotic cases were performed in the Division of General Surgery. There was a continuous increase in the number of robotic procedures performed (Fig. 1). Robotic malfunctions occurred in 18 cases (3.4%). These failures were related to malfunctions of robotic instruments in 9 cases (Table 2). The harmonic scalpel was concerned in all these cases and required instrument replacement. The tip of the instrument (Fig. 2) was the origin of the malfunctions in all cases. Excluding these 9 malfunctions of instruments, the rate of pure system failures was 1.7%. Concerning the robotic arms, we recorded 4 cases of malfunction due to malpositioning of the adapter between the robotic arm and the instrument. Repositioning the adapter resolved the dysfunction in all cases. The optical system was the root of malfunctions in 2 cases. One led to a laparoscopic conversion because of light source failure. The surgical console had 1 major and 2 minor malfunctions. In 1 case, the system froze and stopped working during a gastric bypass. The system was shut down and rebooted successfully. The procedure was finished without additional problems thereafter. The 2 minor dysfunctions were caused by a problem with the audio control. The procedures were still performed robotically. None of the recorded failures led to adverse patient consequences. Only 1 conversion to laparoscopy was required because of the light source problem, which led to a conversion rate because of system malfunction of.2%. All malfunctions were directly related to the robotic system, except 1, which occurred with the Standard or the S

3 86 The American Journal of Surgery, Vol 207, No 1, January 2014 Figure 1 Number of general surgery cases per year (through September 2012). system. Since 2011, only instrument malfunctions and 1 freezing of the system were recorded, occurring on the S and Si systems, at similar rates. Overall, there were more malfunctions at the beginning of our experience (before 2011) than more recently (4.2% vs 2.6%, P 5.35). Comments The safety question of the robotic system remains important, even if various and even advanced procedures have been performed with good outcomes. 3 6 Rapidly, the risk for robotic malfunction has raised questions among the surgical community. Although the robotic approach has been clearly proved safe in terms of complications and mortality rates, 2 many centers continue to scrutinize the specific outcomes of robotics. Recently, a large study showed the safety of the robotic approach for general surgery in a teaching hospital with low morbidity and mortality rates. 2 In fact, there were no specific robotic risk factors for postoperative complications, except multiquadrant procedures. Otherwise, the risk factors were similar to those already described for more standard approaches. The same has been reported as well for urology. 31,32 Yet the interest in robotic system malfunction remains high, and several centers have reported their experiences in various specialties. 8 14,16 18 Even more interesting, in 2008, an extensive review of the US Food and Drug Administration database concerning device failures showed only 168 malfunctions for the da Vinci system between 2000 and Thus, the failure rate seems to be quite low according to the impressive number of robotic procedures performed during these 8 years (estimated to be.50,000). We report herein 1 of the largest series that evaluated the risk for malfunction of the robotic system for general surgery. The results are convincing, with a low rate of failures. Only a few failures were considered major malfunctions (optics and console). Finally, only 1 conversion was attributed to the malfunction itself (malfunction of the light source). If we do not consider problems with the instruments, the system failure rate falls to 1.7%. Of note, there was no morbidity or mortality related to robotic dysfunction. Our findings are similar to those already reported by other teams. Recently, Agcaoglu et al 18 reported a 4.5% failure rate after 223 cases. As in our series, the majority of the malfunctions were related to the robotic instruments, as reported by others as well. 10 In a multidisciplinary study, Kim et al 10 found a system failure rate of 2.4% after 1,797 procedures, with 44.2% of them concerning the instruments; that is similar to our experience. However, there were no specific data concerning general surgery. For urology, large studies have been published and have shown the reliability of the robotic system as well. A multi-institutional study of 8,240 cases showed a critical failure rate of only.4%. 12 More specifically, Borden et al 8 evaluated 350 robotic prostatectomies. They found 2.6% of scheduled procedures that were unable to be completed robotically because of malfunction. There were 3 conversions in their series (.9%) due to system failure. Although uncommon, it is clear that a malfunction can have serious effects, such as financial, logistical in case of cancelation, or psychological for the patient. 8 On the other hand, in an international survey, Kaushik et al 9 reported that 56.8% of the 176 responding urologists had experienced R1 irrecoverable intraoperative malfunction. Of note, these malfunctions required conversion in a majority of cases. In 1 of the largest series published so far, the authors reported a.17% risk for conversion because of robotic malfunction. 10 Interestingly, the malfunctions were not related to specific procedures or to specific robotic models. Yet there was Table 2 Robotic system malfunctions n Type of failure Consequence/resolution Robotic system 9 Console 3 Audio control (2) None Freezing of the system (1) Reboot of the system Arm 4 Adapter Repositioning Optic 2 Light source 1 conversion to laparoscopy Video 0 None None Robotic instruments 9 Damage to harmonic scalpel Replacement

4 N.C. Buchs et al. Reliability of da Vinci system during general surgery 87 Figure 2 a trend; with increased experience, we decreased our system failure rate. Even though we continue to experience minor dysfunctions with the instruments, we have had only 1 critical failure since Others have reported similar decreases in malfunctions of robotic arms. 14 The feeling that the number of malfunctions decreases as experience increases is shared by others as well. 12 Interestingly, a review of the Food and Drug Administration database also showed an impressive decrease in terms of the conversion rate because of device malfunction, from 94% in 2003 to 16% in Thus, with increased experience, the risk for conversion because of a technical failure seems to be reduced. In our experience, the only converted patient occurred during the first part of the study. In addition, the new robotic systems (S and Si) are more advanced technologically and probably more robust than the first generation. Finally, the teams have learned with experience to avoid malfunctions by proper preparation, setup, and instrument handling. Of note, our center is a teaching institution. The level of expertise of the assistant surgeons is broad (student, residents, staff surgeons), as is the range of the procedures we actually perform in our division. Although we might expect a higher malfunction rate in a teaching hospital, our experience shows that the robotic system failure rate can be held to a low and reasonable level with close supervision. Conclusions The robotic system failure or malfunction rate was low. Most of the malfunctions could be resolved during surgery, allowing the procedure to be completed safely. Critical failure is very uncommon but can lead to conversion to either laparoscopy, as was the case in our series, or to open surgery. With increased experience, the system malfunction rate seems to be reduced. References Damage to the tip of a harmonic scalpel. 1. 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