Da Vinci Robot Injury Haunted Portland Woman for Months

Portland, ORIn spite of thousands of the expensive da Vinci robots installed at hospitals across the country, it appears as if the bloom is off the rose for Intuitive Surgical Inc. (Intuitive). Sales of their flagship da Vinci surgical robot are reportedly in decline following years of robust growth, and the US Food and Drug Administration (FDA) has issued a Class 2 Recall in relation to testing deficiencies. What’s more, yet another robotic surgery injury is making the news.

Heidi Carlson of Southeast Portland underwent a standard hysterectomy in September of last year. A da Vinci robotic device was used to assist the surgeon during the procedure. Soon after her procedure, Carlson began experiencing a sharp pain in her abdomen that appeared chronic. As she described to KATU Television in Portland (7/22/13), it just wouldn’t go away.

“Anything [my doctor] suggested, I tried,” Carlson said in a KATU interview. “Like physical therapy. OK, we’ll go try physical therapy. That didn’t work. Well, maybe you should see a pain specialist - get injections. OK, go do that. I’ve heard acupuncture is great. I literally tried everything.”

Months after her surgery, a CT scan finally revealed the source of her pronounced discomfort - a small metallic object that apparently had broken off or dislodged from one of the surgical instruments used by the da Vinci robot. “If they would have just taken an X-ray right after the surgery, or really examined all of the instruments, it could have been prevented,” Carlson said of her da Vinci robot injury.

The hospital, Legacy Emmanuel Medical Center in Portland, is investigating.

Advocates of the da Vinci surgical robot system laud the advancements in surgical precision, and the visual magnification available from state-of-the-art cameras. However, critics cite the disconnect with the patient as the primary surgeon operates the robot by way of a series of controls, losing human tactile touch as a result. Others have commented that surgeons may miss something untoward happening outside their field of vision allowed by the cameras.

It is not clear if Carlson is considering a da Vinci lawsuit. But others have launched cases against Intuitive for problems during surgery allegedly due to da Vinci robot failure.

Meanwhile, Bloomberg (7/12/13) reported last month that a Class 2 Recall was initiated by the FDA over factory testing of various systems related to the da Vinci robot that may not have met compliance standards due to a problem with a piece of equipment used in the testing. Affected by the Class 2 Recall, according to Bloomberg, is Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.

The FDA defines a Class 2 Recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” A spokesperson for da Vinci noted in an e-mailed statement to Bloomberg that 30 systems affected were field-tested following the recall. All systems, according to the spokesperson, passed.

Meanwhile, the San Jose Mercury News (7/19/13) reported that incidents of da Vinci robot injury doubled in the first six months of this year. While thousands of robot-assisted procedures have been performed since the da Vinci robot system first appeared on the market - and Intuitive continues to sell its flagship product to hospitals, logging 143 sales for $215 million for the second quarter of this year - the safety of the system has been called into question nonetheless.

Bloomberg reported in February that the FDA is reviewing the situation with surgeons in the wake of a reported spike in adverse events and da Vinci robot injury that includes, according to Bloomberg, as many as 70 deaths since 2009. It should be noted that da Vinci surgical robots were reportedly involved in procedures in which deaths occurred, but the robot may not have necessarily caused those deaths.