Da Vinci Robot Surgery Injuries and Deaths on the Rise

Problems with da Vinci robotic surgery continue to make headlines across the nation. According to a recent report by Citron Research, a massive increase in the number of MAUDE da Vinci robot surgery deaths and injury reports was noted in 2013. The 2,008 filings were logged at a rate of 400+ a month during the first five months of 2013 alone, states the report. Citron notes that this rate is more than five times higher than any prior period since the da Vinci robot was launched.

In August of 2013, the number of da Vinci robotic injury and death reports totaled 105 – a figure that is more than triple the rate of any previous month. Citron speculates that this spike in numbers may reveal a major policy change at Intuitive Surgical, manufacturer of the controversial robotic system.

71 da Vinci robot surgery deaths since 2000

Da Vinci adverse event reports added to the MAUDE database in August include 73 “injury” or “death” events that are annotated “As part of a legal mediation effort…” in the manufacturer’s notes. In total, there are 40 “legal complaint” reports filed in the last four months, all of which reveal a lag time between the event date and the date reported of between 1-4 years. As reported by the Orange County Register on September 20, at least 71 patients have died from da Vinci robotic surgery complications since 2000, prompting federal regulators to investigate the safety and efficacy of the system.

Controversy stems from many factors, including the mechanics of the da Vinci robot itself and the amount of physician training required before surgeons can use the complex system. At present, questions and doubts linger about the training protocol offered by Intuitive as well as concerns that some doctors have mishandled the device.

Citron Research raises some critical questions regarding the backdating of da Vinci surgery adverse events. The report asks, “Why are so many of these reports backdated – disclosing just now the adverse events from surgeries conducted years ago? How far back in time does the liability extend? How many such cases are being spawned right now, on a track where the investing public won’t find out about them for years to come? How many reports are applicable to current surgeries? Is the frequency of reporting Adverse Events increasing? Why?”

Fatal complications trigger litigation against Intuitive

In 2013, there were between 55 and 60 incidents of punctured, burned or lacerated bowel injuries noted in MAUDE. Some of these da Vinci robotic surgery problems were caught and addressed by the surgeon during the operation, but in numerous cases, the patient was sutured up and sent home, only to return to the hospital at a later date suffering life-threatening infections. The bulk of da Vinci surgeries are routine prostatectomies and hysterectomies – procedures that would never, under normal circumstances, carry such risks. Today, an estimated 80 percent of all prostate removal surgeries are performed using the da Vinci robot.

The American Congress of Obstetricians and Gynecologists (ACOG) concluded that robot-assisted hysterectomies, which happen to be Intuitive’s highest-volume procedure, are not clinically superior to handheld laparoscopic surgery for routine hysterectomy. The organization cautioned that daVinci hysterectomies are more costly and lengthier and should not be the standard of care.

NBC News reports that at least two da Vinci surgical robot lawsuits have been settled out of court to date, while more than two dozen others are pending in court rooms throughout the nation. Most of the cases involve horrific injuries ranging from perforated bowels and burns to septic infections.