Da Vinci Robotic Surgery Adverse Events Reported To FDA So Far In 2013

162017_132140396847214_292624_nThe robotic surgery system known as Da Vinci SI Surgical System (“da Vinci”), which is manufactured, sold, and marketed by Intuitive Surgical, Inc. (“IS”), is being purchased by an increasing number of hospitals throughout the United States and was used in 367,000 surgeries in the United States in 2012, compared to 114,000 in 2008. Almost 1,400 hospitals in the United States (almost 1 in 4) have at least one da Vinci, at a cost of approximately $1.45 million for each system plus at least $100,000 per year for service agreements. About 85% of prostate removal surgeries in the United States are performed with da Vinci and the da Vinci is also widely used in many other surgeries such as gallbladder removal, hysterectomies, heart valve repair, and organ transplants.

How Does The Da Vinci Work?

The da Vinci is a sophisticated three or four-armed robot with a small video camera attached to one of the arms and the other arms equipped with small surgical instruments, all of which are inserted through small ports placed in the patient and are manipulated by the surgeon.

From a seated position, the da Vinci surgeon views true-to-life 3D images through the Vision System that provides 10 times the magnification of the human eye and provides surgeons with six degrees of motion more than possible with the human hand, allowing the surgeon to bend, twist, and maneuver instruments in ways not humanly possible. Thus, the da Vinci provides improved visualization, magnification, and maneuverability for greater surgical accuracy and patient safety.

The da Vinci cannot be programmed or make decisions on its own but requires every surgical maneuver to be performed with direct input from the surgeon.

While the public has recently become more aware of anecdotal stories regarding complications experienced by both da Vinci surgeons and da Vinci patients during and following da Vinci surgeries, we decided to search the FDA’s MAUDE (Manufacturer and User Facility Device Experience) data for adverse events reports regarding da Vinci that have been received by the FDA so far this year (2013).

The following are some examples of MAUDE reports related to da Vinci that had been received by the FDA from IS, from March 14, 2013 to March 29, 2013 (the latest two-week period available). To view all of the MAUDE adverse events reports regarding da Vinci for this year to date, click here:

On March 29, 2013, the FDA received a report from IS that a patient had died during recovery after completion of a da Vinci hysterectomy procedure. A review of the da Vinci system logs showed no system malfunction occurred during the procedure and no further details were made available. Source

On March 27, 2013, the FDA received a report from IS that during a da Vinci partial nephrectomy procedure, the patient side manipulator (“psm”) arm 1 behaved in a sluggish manner. During the surgery, the surgeon reported that he accidentally nicked the patient’s vena cava and during the repair, the da Vinci experienced articulation issues with the instruments installed on the 1 psm and the 2 psm. The manufacturer later determined that the 1 psm was out of specification and that the psm failed an in-house brake drop test and that axis 5 and axis 6 potentiometers had jitter. Source

On March 27, 2013, the FDA received a report in which IS stated, “during a da vinci si prostatectomy procedure, when the surgeon activated  bipolar cautery energy from the footpedal on the surgeon side cart, cautery energy from the monopolar curved scissors (mcs) instrument was activated causing a burn to the patient’s bowel.” The surgeon reported that while he was retracting the patient’s bowel using the maryland bipolar forceps instrument, he heard the alarm from the esu and immediately stopped using the maryland bipolar forceps instrument. The surgeon indicated that he had not touched the footpedal and that the instrument activated when he had not pressed the footpedal. Source

On March 22, 2013, the FDA received a report in which IS stated, “It was reported that during a da vinci si low anterior resection procedure, the hook at the tip of the permanent cautery hook instrument was pulled off and fell into the patient. The fragment was reportedly retrieved and the planned surgical procedure was completed.” Source

On March 22, 2013, the FDA received a report in which IS stated, “It was reported that during a da vinci si hysterectomy procedure, while performing dissection to take down the patient’s bladder, the surgeon punctured the patient’s bladder.” Source

On March 22, 2013, the FDA received a report in which IS stated, “During a robotic assisted hysterectomy the physician stated that the bipolar forceps was “floppy” and he could not control the movement of the forcep. The forcep instrument was removed, cleaned and re-attached to the manipulator and re-test with no success. The physician also reported that the needle driver instrument was not manipulating correctly.” Source

On March 21, 2013, the FDA received a report in which IS stated, “It was reported that during a da vinci s prostatectomy procedure, the customer experienced a problem with blurry vision on the right eye of the surgeon side console. With the assistance of isi technical support engineer (tse), the customer exchanged the scope and found it to be damaged. According to the customer, the gasket seal was broken. They installed a new endoscope, but the right eye was too cloudy. They replaced the camera head and the blue vision cable, but they had no image at all. There were no errors reported from the da vinci robot system. The surgeon decided to convert the procedure to traditional open surgical techniques to complete the planned procedure.” Source

On March 21, 2013, the FDA received a report in which IS stated, “During the robotic procedure, the surgeon wanted to use the vessel sealer. The tech loaded the vessel sealer into arm 1 of the patient cart of the robot. It was witnessed that the vessel sealer will burn out and cut on the first try, afterwards the surgeon tried to use it again and it was witnessed that the vessel sealer would burn only. Another device was needed. There was no harm to the patient.” Source

On March 18, 2013, the FDA received a report in which IS stated, “It was alleged that the patient had a multi-port cholecystectomy … that resulted in an injury to the bowel from the trocar during insertion at the beginning of the case. The patient complained about pain two days after the surgery and returned to the hospital. The patient was readmitted, allegedly septic and an emergency surgery was performed to repair the bowel. The patient expired.” Source

On March 15, 2013, the FDA received a report in which IS stated, “a few days after a da vinci si pyloroplasty procedure, the patient experienced problems with high fever. After consulting with his surgeon, he was brought back to the emergency room for an exploratory surgery. It was alleged that during the open traditional surgery a 3cm hole was found on the patient’s bowel. It was reported that the surgeon removed 6 of the patient’s colon and a colostomy bag was installed.” Source

On March 15, 2013, the FDA received a report in which IS stated, “approximately two weeks after successful completion of a da vinci si single site cholecystectomy procedure performed on … , the patient experienced post-surgical complications as a result of an alleged bowel perforation. Reportedly, the patient underwent a surgical procedure using open surgical techniques to repair the affected area.” Source

On March 15, 2013, the FDA received a report in which IS stated, “It was initially reported that during a da vinci si sigmoid colectomy procedure, the customer experienced a problem with one of the patient side manipulator (psm) arms. The customer reported that the psm arm 1 was not following the movements of the surgeon properly during the case. It was alleged that the bed side assistant was looking at the drapes when the arm moved forward and contacted the patient’s aorta. The customer converted to an open procedure and a vascular surgeon was called to repair the damage. It was also reported that the site was unsure if the arm was touched or if the surgeon had his head in the viewer with his hands off the master. The surgeon reported to the clinical sales representative: it is clear to me that there was pent up energy stored on the arm of the robot. When this was released the instrument shot forward with a force and at a speed greater than humanly possible. It then appeared to set back half way between the starting point (where it was not functioning) and the point of maximal contact in the retroperitoneum. I am not sure whether the recoil after the stabbing was the robot returning to a rest or me instinctively pulling back on the controls. The instrument involved in the incident was the harmonic ace instrument in port 1 in the rlq (the port itself was pushed in beyond the remote center because of the patient’s body habitus and the need for additional length while addressing the flexure). It had been working normally until about 30 seconds prior to the incident when it stopped responding to commands at which point isi technical support had the or staf[f] check the field and she identified no physical barriers and noted there were no error messages.” Source

On March 14, 2013, the FDA received a report in which IS stated, “It was reported that post a da vinci s hysterectomy procedure, it was discovered that the patient sustained rectal/colon injuries, which required the patient to undergo additional surgical procedures.” Source

On March 14, 2013, the FDA received a report in which IS stated, “It was reported that prior to starting a da vinci s prostatectomy procedure, during startup of the da vinci s system, the customer experienced a problem with error code 45341. The site contacted isi for technical support engineering (tse) assistance. Review of the site’s system log by the tse found that the system error code 45341 was related to the video process assembly on the da vinci s robot system. The surgeon made the decision to complete the planned surgical procedure using open surgical techniques.” Source

What we glean from the MAUDE reports referenced above is that complications when using da Vinci may be due to the high-tech, advanced equipment itself; the actions of the surgeons using the da Vinci; and/or to the training, experience, and competence of da Vinci surgeons.

In any event, if you or someone you know may have been injured during da Vinci surgery, you should promptly contact a local da Vinci claim attorney to investigate the cause of your injuries  and whether someone may be liable to compensate you for the harms caused during da Vinci surgery.

Click here to visit our website or call us toll-free (800-295-3959) to be connected with da Vinci malpractice lawyers in your state who may be able to assist you with your da Vinci claim.

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This entry was posted on Sunday, April 14th, 2013 at 1:35 pm. Both comments and pings are currently closed.

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