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Davinci robot and hernia surgery- cleared procedure?
I see many discussions around the robot being used both with hernia repair surgeries as well as mesh removal.
I also see see many of the doctors listed receive payments from the manufacturer of the davinci robot, Intuitive Surgical. – Google dollars for docs probublica.
Doctors, I am sure you can can point me to the fda 510(k) approving hernia repair and mesh removal as a cleared procedure with the davinci robot.
In addition, I have concerns around a new intuitive Surgical recalls with the endowrist instruments stating “Use of an instrument for a task other than the instruments designed use may result in breakage or damage;”
thank you!
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30 Replies
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Thank you for the comments. Much appreciated!
my comment on incorrectly reported event types is not extreme. I have gone through the Maude database and identified an ENORMOUS number of incorrectly reported events by Intuitive Surgical- deaths reported as malfunctions and injuries.
Looking at the recalls and design defects from the recalls, there is no amount of surgeon training that can prevent arcing due to a defective instrument with wires breaking at the weld or insulation failure. I feel the main problem around training with the surgeons is from their lack of knowledge about the defective design allowing them to create what is really a remote controlled laparoscopic surgery. Training them and educating surgeons on the robot’s defects is a priority.
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It’s very good to do research on these topics. We have a very large number of non-physician contributors on this site who do an excellent job at commenting and educating those that post here.
I am here to help provide some clinical relevance to the discussions.
– The Bleeding Edge discussed the higher risk of suture failure when sewing the vaginal cuff robotically than with open/laparoscopically with the robot. This was a learning-curve issue for the surgeons and not related to the robot itself.
– It is a very extreme comment to make that “there are an enormous number of deaths that have not been reported.” Deaths are tracked at all levels of medical and surgical care and analyzed from all different aspects. In surgery, we have mandatory meetings weekly to discuss complications and death, called “Morbidity and Mortality conference.”
– It is unfair to assume anything that we use in life is a perfect product. Cars are not perfect. Surgical instruments are not perfect. The goal is to constantly improve with the goal of improving outcomes. The patents you mentioned are looking at improving the current graspers to allow varying strengths of grip within one grasper, as opposed to the current situation where there are various graspers, each with its own grip strength. The product is supposed to be be out this month or next month for surgeons to use.
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Dr. Towfigh, you receive payments from Intuitive Surgical it appears. Is this data inaccurate? https://projects.propublica.org/docdollars/doctors/pid/149074
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Patents to fix da Vinci defective design
Grip force control in a robotic surgical instrument
Patent : 20180140365
Description of Patent: Mechanisms are typically relatively stiff and capable of generating excessive amounts of clamping force. Accordingly, the use of such a high mechanical advantage mechanism may in some circumstances result in the application of an excessive clamping force that damages the tissue being clamped. Thus, there is believed to be a need for a surgical assembly that is operable to generate clamping forces in a controlled manner
Associated MDR indicating need for new design : Event Description: 2955842-2018-10163: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED GRASPER INSTRUMENT WAS NOT GRASPING THE TISSUE ADEQUATELY. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PLANNED PROCEDURE AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. Manufacturer Narrative: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE WAS CONDUCTED AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE INSTRUMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.
Construction and use of low tension medical instrument
Patent : 20180132957
Description of Patent : The embodiment of the invention is a method for constructing and using a medical instrument. In particular, a medical instrument having one or more tendons that extend from a proximal end of the instrument to an actuated element at a distal end of the instrument can be constructed without tension in the tendons or with tensions below those required for normal operation of the instrument when in use attached to a manipulator. The construction process may thus be simplified, particularly because some manufacturing processes are made more difficult by pre-tensioning of tendons. The instrument without tension in the tendons can be used by first engaging the medical instrument with a manipulator to create tension in the tendons and then operating the manipulator to pull the tendons and actuate the medical instrument.
Associated MDR indicating need for new design : 2955842-2018-10158 : THE MCS INSTRUMENT INVOLVED WITH THIS EVENT HAS BEEN RETURNED TO ISI FOR EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. IT WAS FOUND THAT THE TUBE EXTENSION OF THE MCS INSTRUMENT WAS BROKEN AT THE DISTAL END. THE BROKEN PIECES WERE RETURNED WITH THE INSTRUMENT. THE KNOWN COMMON CAUSE OF THIS FAILURE IS DUE TO MISHANDLING/MISUSE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, FRAGMENTS FROM THE INSTRUMENT’S SHAFT ALLEGEDLY BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON COULD NOT RETRIEVE THE FRAGMENTS THROUGH THE TROCAR, HENCE HAD TO ENLARGE THE INCISION IN ORDER TO RETRIEVE THE FRAGMENTS. BASED ON FAILURE ANALYSIS FINDINGS IT WAS DETERMINED THAT THE DAMAGE TO THE INSTRUMENT WAS DUE TO MISUSE/MISHANDLING AND NOT TO A MALFUNCTION OF THE INSTRUMENT
Electrically conductive reducer device, related systems, and related methods
Patent #20180132890
Description of Patent : Some surgical tools that utilize electrical power are susceptible to capacitive coupling with other surgical tools, such as other instruments, cannulas, etc. during use. Capacitive coupling can generate a leakage current in the surgical tool which, if not dissipated in a controlled and predictable manner, could potentially result in misdirection of electrical energy. In some cases, the cannula is made from a conductive material, such as a metal or alloy, and contact or sufficient proximity between the conductive cannula and a conductive portion of the instrument permits a conductive pathway from the instrument to the cannula to dissipate any leakage current to the patient’s body wall through the outer surface of the conductive cannula, with the patient typically being further electrically grounded via a return pad to a ground terminal. A need exists to provide a conductive path between a conductive cannula and an instrument that is inserted through a reducer device positioned within the cannula. It is desirable to provide such a conductive path while providing reducer devices that are relatively inexpensive to manufacture.
Associated MDR indicating need for new design : 2955842-2018-10142 Defect : Arcing IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE INSULATION ON THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS CHARRED AND THAT POSSIBLE ARCING OF ELECTRICAL ENERGY HAD OCCURRED. NO ISSUES WERE REPORTED DURING THE ACTUAL SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY. Manufacturer Narrative: INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT “THE INSULATION OF THE CAUTERY IS CHARRED.” THERMAL DAMAGE WAS FOUND AT THE INSTRUMENT¿S WRIST. THE DISTAL CLEVIS EAR WAS CUT OFF TO INSPECT THE CONDUCTOR WIRE. THE CONDUCTOR WIRE WAS FOUND TO BE BROKEN AT THE WELD CAUSING THERMAL DAMAGE ON THE DISTAL CLEVIS, CONDUCTOR WIRE CAP, AND YAW PULLEY. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE DAMAGE FOUND AT THE WELD DURING FAILURE ANALYSIS SUGGESTS THAT UNINTENDED ARCING OCCURRED. ALTHOUGH, NO PATIENT HARM WAS REPORTED, IF THE MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.
As you know, the temperature of an electrical instrument can exceed 1000 degrees C.
Data shows that 100% of the reusable robotic laparoscopic instruments used with the da Vinci platform leak electric energy. Previous studies have reported prevalence of insulation defects in laparoscopic instruments at a lower rate of 19% to 39%.”…
…”Within a short period (10 seconds), sufficient heat from capacitance may build up from the corona discharge at the interface of the active electrode and nearby conductor to burn the insulation of the electrode, resulting in direct contact (arcing, sparking, shorting) of the electrode to the adjacent conductor. …”
…”Each spark reaches temperatures of 700C to 1000C, and sparks are delivered at 30,000 per second in the coagulation mode. Under sparking conditions, thermal injury to tissue is instantaneous, inevitable, and severe. This is especially true in hollow organs, such as bowel, where a single spark can destroy the mucosa, which may lead to delayed perforation 3 to 15 days postoperatively”…
https://www.researchgate.net/public…ci_R_Robot-Assisted_Surgery_An_In_Vitro_Study
Non-absorbable and synthetic materials
Among the various groups, prosthetic materials falling under this category especially the polypropylene (PP), polyester (PE), and expanded polytetrafluoroethylene (ePTFE) based meshes are the one used extensively. Their biological properties with the related clinical outcomes are discussed below
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Due to the below listed KNOWN ISSUES and patents to fix the issues (but not yet implemented,) I have concerns and request immediate action around regulating these unapproved procedures for the Class 2 da Vinci robot. I would advise mandatory and immediate testing, QA, and then formal approval for the procedure expansion, and strictly prohibiting the use of the da Vinci for these procedures until this is approved. There are no industry standards set around how much pressure by the da vinci robot the Essure devices can withstand when being pulled from the patients fallopian tubes. There are also no industry standards establishing how much heat and for how long mesh can be exposed to a cauterizing instrument before it starts to melt.
Also, there are NO training courses provided by Intuitive Surgical on these procedures. There are rogue surgeons (like the one below) out providing training to other surgeons on this unapproved and untested da vinci procedure.
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Thank you Doctor, for the well thought out reply. As you can see below, the arcing issues etc are still occurring today along with all the other items discussed.
Inaccurate reporting of EVENT TYPE :
I believe there are an enormous number of deaths that have not been reported. I would advise for you to initiate an investigation to scrub the MAUDE database for all Intuitive Surgical, Intuitive Surgical Inc., Intuitive and ISI adverse event reports that contain anything in their descriptions etc. with the words – death, died, passed, demise, etc. and analyze the results.
I did this simple task for ONE month and found a mistake in that single small timeframe alone.
Even with all the attention Intuitive Surgical is getting from The Bleeding Edge, they are still failing to correctly identify the Event Type in the Adverse Event reports to the FDA. Below is an example released this month. The patient died (or they say “expired”) but the event type is labeled as “injury.”
“Based on the information provided at this time, this complaint is being reported due to the following conclusion: a patient reportedly underwent a da vinci-assisted surgical procedure, experienced unspecified operative complications, and subsequently expired from an unknown cause. ”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=7680726&pc=NAY
2) Da Vinci robot should not be used for removing MESH or ESSURE:
These procedures have not been cleared with the FDA.
Quote from Dr. Julio Novoa OBGYN “ I a m very concerned with GYNs recommending the DaVinci robotic technique over the traditional LAVH/BS. In the hands of a skilled surgeon, only one or two laparoscopic ports need to be placed with the removal of everything through a vaginal approach. The use of the DaVinci rarely improves the technique or outcome of the procedure. On the contrary, the DaVinci most often increases the number of ports from 2 to 4 or 5 sites and increases the s…”
https://essureproblems.webs.com/essure-removal-information
And from a new Field Service Notice from Intuitive Surgical (attached)
“using the MCS to retract anatomy or using an instrument or grasp hard objects may contribute to breakage…”
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Interesting discussion regarding robotic surgery.
Here is my take on it:
– Robotic surgery is an advancement in surgical technology. Because of the shorter learning curve than laparoscopic surgery for many complex operations, it has allowed more surgeons to offer minimally invasive surgery to their patients. In the majority of operations, minimally invasive approach options result in less infection rate, less postoperative pain, and shorter recovery and faster return to work. For those of us that already use laparoscopic techniques, the robotic-assisted technology allows us to perform operations that we would not be able to perform laparoscopically. In some situations, such as mesh removal, my data has shown that robotic-assisted mesh removal is safer and with better outcomes than laparoscopic removal. The paper is due to be published soon.
– Robotic surgery has made a lot of advances since its original introduction decades ago. It is continuing to do so.
– The choice of instruments depends on the type of tissue handling planned. There are varying grip strengths. E.g., you would typically not use the same instrument to grasp mesh as you would to handle intestine. The reverse is okay.
– Arcing can occur with any electrical instrument, whether open, lap, or robotic. Robotic instruments have the most safety precautions, of the three techniques, for arcing. They all have a gel-type cover to minimize exposure of electrical current to only the tip. The videos shown are of extremely old instruments with tear in the gel safety cover. I am not sure what year and in which country that was filmed. It is clearly below the standard.
– The instruments typically have a 10-use lifespan. This is also another safety precaution.
– There are a lot of reasons for the robot not being used in pediatrics: the instruments are wider than many laparoscopic instruments (3-5 mm vs 5-8 mm) and most operations in children are not performed laparoscopically to begin with. That said, the robot is superior to the laparoscope in “tight” areas, such as the pelvis, hence its prevalence in urology, colorectal surgery, gynecology, head and neck surgery.
– The only ones who make money from the robot are the investors/owners of Intuitive Surgical. It is a very expensive tool. Insurance companies do not pay any more than laparoscopic or open operations for the operations performed by the robot. Hospitals typically lose money on the robot, to the point where many have decided not to buy it. This is also another reason why most European (and other) countries have chosen not to get on the robotic bandwagon, as socialized medicine cannot afford a $2M toy.
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This is my concern – obviously, based on this patent application, there are issues with the gripping force of the davinci instruments. https://patentscope.wipo.int/search/en/detail.jsf;jsessionid=340FF2EC4204D7F0C78345F71A3963C1.wapp1nA?docId=US217775404&recNum=320&office=&queryString=&prevFilter=&sortOption=Pub+Date+Desc&maxRec=69349346
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Which robotic instruments are used (to grasp etc) the actual mesh?
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I had laproscopic surgery just over 3 weeks ago. The surgeon can do it with or without the robotic tool; it all depends if the surgery room is booked. For my surgery the surgeon did laproscopic robotic. After the surgery I had minimal pain – only needed tylenol now and then. After 2 weeks pretty much back to normal. Glad I did it.
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Jnomesh is correct. Robotic surgery is advanced laparoscopic surgery. Some surgeons do the initial hernia repair with the robot and more and more are using robotic surgery to remove the mesh. The 3D imaging is clearer, the robots arms can move in ways a human hand cannot, removal is very time consuming and causes fatigue and hand tremors, the robot eliminates that.
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Like with any new invention, it will take time to perfect it. This is all the more reason to be cautious about robot assisted surgery.
“Things that are complex are not useful, things that are useful are simple.”
~ Mikhail Kalashnikov -
All of this, in addition to the fact it isn’t at all superior in tight spaces (notice how the robot has not been embraced by pediatrics) added surgery times and costs, along with all the added risks and recalls, I will pass on future davinci surgeries. It is a gimmicky and dangerous remote controlled laparoscopic surgery from my research.
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Here is one concern : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831508/
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I understand your concern da Vinci. It’s good that you are doing your own research. The sparks or arcs are avoidable though… by not doing a robotic surgery. Is there any particular reason why you prefer laparoscopic or robotic surgery?
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My concern is that the davinci robot still has constant reports of malfunctions of arcing. Within a short period (10 seconds), sufficient heat from capacitance may build up from the corona discharge at theinterface of the active electrode and nearby conductor to burn the insulation of the electrode, resulting in direct contact(arcing, sparking, shorting) of the electrode to the adjacentconductor. Each spark reaches temperatures of 700C to1000C, and sparks are delivered at 30,000 per second in thecoagulation mode. Undersparking conditions, thermalinjuryto tissue is instantaneous, inevitable, and severe.
Mesh melts at : 130 to 171 °C (266 to 340 °F; 403 to 444 K)
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So da Vinci is good for implantation and explantation of meshes? And even superior for explantation than traditional laparoscopy? Regardless of da Vinci model? I believe Xi is the latest generation of this system, gen 4. I supposed it doesn’t have to be this latest system? This is the only one that has specific wording about general (hernia) surgery in the FDA document.
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