BLM represented one of the surgeons involved in an inquest in November 2018 which dealt with the death of a 69 year old patient following, and as a result of, robotic surgery to repair a diseased heart valve.
The coroners’ narrative conclusion to the inquest stated that complications had occurred during the procedure, including the unexpected departure of the two proctors before the surgery had finished. The proctors were a surgeon and an anaesthesiologist from outside the UK, who were both experienced in the use of this particular robot, and whose hospital department had already provided training for the use of robots in this particular surgery.
The operation was the first heart valve repair procedure to be carried out using robotic assistance in this hospital, and in fact one of the first in the UK, and the first time the primary surgeon had ever used a robot. Amongst other things, the inquest looked at the extent of training on robotic equipment undertaken by the primary surgeon, and the engagement of the proctors.
The coroner made a ‘Prevention of Future Deaths’ report to the relevant hospital and to the Royal College of Surgeons, setting out her concerns and recommending action be taken to establish a policy to deal with the current “absence of any benchmark” for training, and the use of expert proctors.
This case has been widely reported in medical journals, as well as the press. A rise in the use of robotic systems (currently still under human control, but with possibilities in the future for fully automated surgery such as suturing) in hospitals has been predicted over coming years, and is already well underway in the US and some parts of Europe. There are undoubted benefits, in comparison to conventional (open) surgery.
However, there are associated risks, as this case highlights, and we would be surprised if it were to be the only such case. There is an ongoing debate amongst medical professions on both sides of the Atlantic as to whether the purported advantages of robotic surgery outweigh the potential costs, both human and financial. Where the US leads other countries tend to follow and there have in fact been a number of US lawsuits arising from alleged failings in robotic surgery, some involving fatalities.
Robotic surgery in the US
Researchers from the University of Illinois, Michigan Institute of Technology and Rush Medical Center published a manuscript in 2015 entitled ‘Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data’, utilising data from the Manufacturer and User Facility Device Experience.
The study noted that from 2007 to 2013 1.74m robotic surgical procedures were performed in the US. Around 86% of these were urological or gynaecological procedures. In the period from January 2000 to December 2013, the data recorded 8061 “device malfunctions”, 1391 patient injuries and 144 patient deaths.
Adverse incidents included electrical arcing, sparking or charring of instruments and the falling of broken or burnt pieces of instrumentation into the patient’s body. Such incidents were said to have contributed to 119 injuries and one patient death.
This article was co-authored by healthcare partners Katie Costello and Greg McEwen.
BLM regularly advises healthcare professionals for the purposes on an inquest – if you require any assistance advice then please contact the BLM Healthcare Team.