Study
No. reports (years)
System under study
Surgical specialties
Murphy et al. [7]
38 system failures, 78 adverse events (2006–2007)
da Vinci system
N/A
Andonian et al. [8]
189
(2000–2007)
ZEUS and da Vinci
N/A
Lucas et al. [9]
1,914
(2003–2009)
da Vinci system models dV and dVs
N/A
Fuller et al. [10]
605
(2001–2011)
da Vinci system
N/A
Friedman et al. [11]
565
(2009–2010)
da Vinci instruments
N/A
Gupta et al. [12]
741
(2009–2010)
da Vinci system
Urology, gynecology
Manoucheri et al. [13]
50 injuries/deaths (2006–2012)
da Vinci system
Gynecology
Alemzadeh et al. [1]
10,624
(2000–2013)
da Vinci robotic systems and instruments
Gynecology, urology, general, colorectal, cardiothoracic, and head and neck surgery
Instrument or Robotic Device Malfunction: Mortality and Injury Association
Malfunctions are infrequent, and the need to abort or convert to another modality is rare. The types and outcomes of these device malfunctions have changed with time and robotic system.
Overall rates of equipment malfunction occurred among 0.5–4.6%, this percentage varied according to the experience and the number of cases performed by the group of surgeons [14–16]. In the review group at the University of Illinois [1], five main categories of malfunctioning devices and instruments were identified, either that they had an impact on patients, either by injuries and complications or by interrupting the progress of surgery and/or prolonging operative times. This division also has the highest impact for the analysis of robot failures, since it covers the largest number of cases studied (2.9 million records) and cases of adverse events reported (10,624).
As the da Vinci robotic system is made up of several parts of software and hardware, the shortcoming is that each part might cause an unexpected failure.
System Errors and Video/Image Problems
These are the most reported with 7.4% of the adverse events and were the main cause of interruptions of any surgery. Including system reboots, the conversion of proceedings to a non-robotic (59.2% of all conversions) approach, and need to abort/rescheduling of procedures (81.8% of all cases).
System errors have increased by robot’s existing security mechanisms after troubleshooting detection that cannot be recovered autonomously; most of the time, it is corrected with a manual system reset (recoverable error), even though there are cases in which the robotic procedure requires to be stopped (unrecoverable error).
Falling Pieces or Burnings in the Patient’s Body
They constituted approximately 1557 (14.7%) of adverse events. In almost all these cases, the procedure is interrupted, and the surgical team spent some time looking for the missing pieces to be recovered from the patient (in 119 cases an injury to the patient was informed, and 1 death was informed).
Instruments Electrical Arcs, Sparks, or Burning
Concerning burns or holes on tip covers, they constituted 1111 reports (10.5%) of the events, which led to almost 193 injuries such as burn tissue.
Failures of instrument tip insulation accessories such as the monopolar scissors are included in this category. Studies showed 25–33% of insulation failure accessories after a single surgical use. Single use of each isolation device is recommended to prevent unnecessary patient morbidity [18].
Unintended Operation of Instruments
Uncontrolled movements and spontaneous switch On or Off occurred in 1078 adverse events (10.1%), including 52 injuries and 2 deaths.
Malfunctions That Could Not Be Classified into Another Criteria, such as Breaking of Cable and Instruments
It is found in the medical literature that despite a relatively high number of reports, the vast majority of procedures were successful and no problems were present. In the analysis with most reports, the number of injuries/death events per procedure has remained relatively stable since 2007. However, the total number of failures reported per procedure (0.46%) was six times below the average number of malfunction by the procedure (3%). Also the total number of injuries and deaths reported by procedure (0.08%) was almost the same as the predicted for robotic surgery complications [19], but in a less magnitude than the lower rate of complications reported for robotic surgery in previous studies (2%) [20].
Preventative or Recuperative System Measures
In practice, the use of a robotic platform interface is a sophisticated machine with surgeons in an area of patient care and safety. From a technological point of view, the use of security practices and controls, substantially improved in its design, operation safety, and validation of robotic surgical systems, could prevent situations of failure and its consequences.
Some Recommendations to Minimize Patient’s Risk
Human-machine interfaces and improved surgical simulators that train surgical teams to handle technical problems [21, 22] and evaluate their actions in real time during surgery.Stay updated, free articles. Join our Telegram channel
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