Patient Dies After Undertrained Surgeon Uses Intuitive Surgical's da Vinci for Mitral Valve Surgery
Posted on November 08, 2018 by Medtech[y] Staff
According to an article from the DailyMail, a patient died in 2015 from a relatively routine mitral valve surgery that was performed in conjunction with Intuitive Surgical's da Vinci robot. During an inquest into the death, the coroner shared that, "Mr Pettitt died due to complications in an operation to treat Mitral valve disease and in part because the operation was undertaken with robotic assistance."
Based on the patient's euroSCORE, the procedure had a 98% to 99% chance of success if an open procedure was performed. However, the surgeon, Sukumaran Nair, decided to use the da Vinci Surgical Robot versus an open approach.
What went wrong?
- Dr. Nair had never used the da Vinci before in a live procedure and admitted to "Running before he could walk". He added, "At the time, I should have gained more experience and my clamp times would have been shorter with time." Additionally, the surgeon shared that he missed vital training sessions in Paris and may have required "more dry-run" training before using the da Vinci in a live procedure.
- The surgeon and assistant reported that communication was difficult due to a 'tinny sound' emanating from the da Vinci.
- Assistent surgeon had to raise his voice to communicate with Dr. Nair that the sutures in the patient's heart were not being placed in an 'organized fashion'.
- Representatives from Edwards Lifesciences walked out mid-way through the operation. It should be noted that Edwards representatives would have no expertise in using a da Vinci system as their company makes the heart valves that were used in this procedure.
The botched six-hour procedure launched a criminal inquiry with no charges filed as of yet. Dr. Nair was ultimately fired from Newcastle's Freeman Hospital and the hospital ended their robotic heart program.
Intuitive Surgical's da Vinci robotic system was FDA approved in 2000 and has become widely adopted for a variety of procedures in the United States. In general, heart procedures make up a very small percentage of the systems overall usage. Medical Device companies have strict training programs for surgeons and it is very important to note that this particular surgeon never should have used the da Vinci system based on their lack of training with the device.
You can read the original article here.
Learn more about Intuitive Surgical and their da Vinci Surgical Robot