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More Questions About Safety of DaVinci Robot Surgery

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Seattle, WAMore questions are being raised about the safety of the DaVinci robot and the possibility of a DaVinci robot injury as more lawsuits are being filed against the maker of the surgical robot. Although the robot’s maker says it stands behind the safety of the device, some patients say they suffered serious injuries because of the DaVinci robot.

Reporting for MSN News (6/18/13), Riya Bhattacharjee writes that at least one woman reportedly suffered injury after a robot surgery for a hysterectomy. The patient says her small bowel fell out of her vagina five weeks after her hysterectomy. She reportedly filed a lawsuit against Intuitive Surgical Inc, maker of the robot, in December 2012.

The report notes that Intuitive currently faces at least 25 lawsuits across the US, including a wrongful death lawsuit in which the patient allegedly suffered burns to her arteries and intestine and died two weeks following surgery.

Intuitive has said it stands behind the safety of its DaVinci robot.

But the American Congress of Obstetricians and Gynecologists (ACOG; 3/14/13) issued a statement about robotic surgery, warning that it is not cost-efficient and is “not the only or the best minimally invasive approach for hysterectomy.”

American Congress of Obstetricians and Gynecologists President James T. Breeden went on to write that “there is no good data proving that robotic hysterectomy is even as good as - let alone better - than existing, and far less costly, minimally invasive alternatives.” The ACOG advises women that laparoscopic hysterectomy is also less invasive than traditional hysterectomy and less costly than robotic surgery.

Meanwhile, a report by Citron Research (“Intuitive Surgical: Angel with Broken Wings or the Devil in Disguise?”; 1/17/13), which focuses on Intuitive stock, notes that the FDA’s adverse event database has 4,600 complaints about the DaVinci robot, although those complaints involve everything from events that caused no harm to patients - such as an error code being detected when the robot was not in use - to life-threatening injuries. Citron also notes that more than 80 percent of the reports to the database are from the years 2007 through 2012.

According to the report, the most common injuries were perforations, lacerations and tears, followed by burns from electrical discharge. The report also noted that often the patient is sent home and the surgery is considered successful. It is not until days or weeks later that complications, including internal bleeding or infection, arise.

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