A stray electrical arc from a surgical robot burned a Florida woman’s small intestine during a colon cancer procedure and the error caused her death, a federal lawsuit is alleging.
The suit, filed by Delray Beach, Florida, resident Harvey Sultzer in U.S. District Court in West Palm Beach, claims that Intuitive Surgical Inc. failed to warn his wife, Sandra Sultzer, of issues that would have caused her to forego use of the company’s da Vinci surgical robot for her procedure in September 2021.
The company also failed to safely design its product “so that stray electrical energy would not burn the insides of patients without the knowledge or control of the operating surgeons,” and failed to properly train surgeons how to use the device, the lawsuit says.
The lawsuit notes that the da Vinci robot is a multi-armed surgical device, introduced in 1999, that’s controlled remotely by surgeons with help of an onboard camera. The instruments include forceps, scissors, scalpels and other surgical tools.
Intuitve Surgical did not immediately respond to an email sent to its corporate communications department seeking comment about the lawsuit. Because the lawsuit was filed on Tuesday, no defense attorney is listed.
The company’s financial reports, filed to the Securities and Exchange Commission, mention an undisclosed number of pending lawsuits and state that the company disputes the allegations.
The Sultzer lawsuit alleges Intuitive Surgical sells the instruments to hospitals that have no experience in robotic surgery but relies on the company to train its surgeons how to use them.
Most of the instruments that the robot uses are disposable or can only be used for a limited number of procedures before they have to be replaced, the suit says. As a result, the company relies on volume of surgeries to make much of its income, it says.
When Sandra Sultzer underwent surgery to treat her colon cancer at Baptist Health Boca Raton Regional Hospital, she experienced “thermal injury (to her) small intestine, causing a perforation which required subsequent medical intervention and caused physical and emotional injury, and ultimately her death,” the lawsuit claims.
The suit says that Sandra Sultzer’s injury and death was not an isolated incident involving the da Vinci device. Currently, Intuitive Surgical is named as a defendant in about 93 product liability lawsuits, the suit says.
Among “thousands of injury and defect reports” received by the company about the device, “the most dangerous injuries arose from burns to internal organs caused by the discharge of electricity, caused by the robot’s instruments inside the patient,” the lawsuit says.
In 2013, the Food and Drug Administration conducted an investigation into injury reports and sent a warning letter to the manufacturer concluding that it had “concealed information from the FDA, secretly recalled defective parts, and ignored known injuries to patients in its design process of critical da Vinci instruments,” the lawsuit cited.
The FDA requires manufacturers, distributors and user facilities to report adverse events involving medical devices to a database it calls MAUDE, for About Manufacturer and User Facility Device Experience.
In March 2013, Intuitive Surgical issued a statement saying it revised its reporting practices to the database, and the change would increase the number of events in the serious injury category. It also noted that the most common type of malfunction report involved broken instrument cables that could be easily replaced.
Of hundreds of complaints received between July 2009 and December 2011, the “vast majority” concerned a rubber sleeve placed on the end of certain da Vinci instruments that were designed as an insulating device to prevent electricity from radiating out, the suit says.
But the sleeves had cracks or slits that prevented the sleeves from properly insulating the metal instruments and allowed electricity or sparks to escape — or arc, the suit says.
“Because the arcing usually occurred outside of the surgeon’s camera field of vision, blood vessels and organs were burned without the medical team’s knowledge,” the complaint states.
Intuitive Surgical’s most recent annual report filed with the SEC describes a global operation that has developed and improved a large offering of products since introducing the da Vinci surgical system in 1999.
A long list of clinical applications stem from the company’s focus on five specialties — general surgery, urologic surgery, gynecologic surgery, cardiothoracic surgery, and head and neck surgery. Key procedures include hernia repair, colon and rectal procedures, cholecystectomy, bariatric surgery, hysterectomy, and lobectomy, among others.
The company also focuses on minimal invasive biopsies in the lung.
Through Dec. 31, the company was providing service for 8,606 da Vinci surgical systems, including 5,111 in the United States, which were used to perform 2,286,000 surgical procedures in 2023, according to Intuitive Surgical’s 2023 financial report, filed to the Securities and Exchange Commission.
The financial report describes “a number of” product liability lawsuits filed in various state and federal courts.
“The plaintiffs generally allege that they or a family member underwent surgical procedures that utilized the da Vinci surgical system and sustained a variety of personal injuries and, in some cases, death as a result of such surgery,” the company said.
Allegations in the lawsuits include that plaintiffs’ injuries resulted from purported defects in the system and/or failure of the company to provide adequate training resources to surgeons, the financial report said. “The cases further allege that the company failed to adequately disclose and/or misrepresented the potential risks and/or benefits” of the system, the report said.
“The company disputes these allegations and is defending against these claims,” the SEC filing says.
In 2018, NBC News posted a report about Intuitive Surgical and the da Vinci device.
The story focused on an Iowa woman who said she sustained a burn to her ureter and damage to her colon during hysterectomy procedure involving a da Vinci device in 2015 and said her prognosis called for a permanent colostomy. The report noted that the woman sued Intuitive Surgical in 2017 but later voluntarily withdrew the lawsuit.
NBC News said it spoke to more than a dozen patients who say they were burned or otherwise injured during surgery involving the device.
In a statement to NBC News in 2018, Intuitive Surgical said its mission “is to help surgeons safely and effectively improve patient outcomes and decrease surgical variability.” It added, “While any surgery regardless of modality carries risk, the best evidence of the safety and efficacy of robotic-assisted surgery can be found in the more than 15,000 peer-reviewed scientific publications that are fully grounded in scientific method and that, in aggregate, support the safety and efficacy of our systems.”
The NBC News story said that more than 20,000 adverse events had been filed to the FDA’s MAUDE database over the past 10 years related to the da Vinci robot.
Of those, nearly 17,000 were classified as device malfunctions. More than 2,000 involved injuries and 274 were categorized as deaths, the network reported.
In 2023, the number of adverse events related to the da Vinci device filed in the database totaled 3,098, the South Florida Sun Sentinel found.
Ron Hurtibise covers business and consumer issues for the South Florida Sun Sentinel. He can be reached by phone at 954-356-4071, on Twitter @ronhurtibise or by email at rhurtibise@sunsentinel.com.
Source: Orange County Register
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