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Intuitive Surgical Issues Limited Recall for 30 da Vinci Robots

Amid an ongoing FDA investigation into complications with da Vinci robotic surgery, the agency has recently announced a Class 2 recall on 30 da Vinci robots that may not have been properly tested to meet compliance standards. Bloomberg reported on the da Vinci robot recall, which included the da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.

Da Vinci robot manufacturer Intuitive Surgical issued an Urgent Device Correction notice to all affected customers on June 27, according to the FDA. Intuitive says that the affected robots have since been checked in the field and passed re-testing without problems.

Limited Da Vinci robot recall issued for improper testing methods

A Class 2 recall is defined by the FDA 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.” Though the da Vinci surgical system has been used without complaint in millions of procedures, dozens of former patients have reported injuries ranging from torn blood vessels and thermal burns to lacerated and punctured organs.

In January, the FDA began an in-depth examination of the safety of da Vinci surgery by surveying doctors about their experiences with the system. Federal regulators hope to glean valuable information that may shed light on the rising reports of complications with da Vinci robotic surgery. Used for prostate removals, hysterectomies and other laparoscopic procedures, the system has been linked to 70 reports of death since 2009, according to Bloomberg News.

Prominent figures in the health care community, and at least one state medical board, have also warned doctors to consider potential da Vinci surgery risks and benefits when identifying possible patients. This past May, Intuitive alerted hospitals that the da Vinci “Hot Shears” could cause electro-thermal burns as the components could develop tiny cracks from which the energy could seep into the tissue.

In 2012, the high-tech robot was used in 400,000 surgeries throughout the nation.

Growing reports of injuries linked to the da Vinci robot

As of September 2009, at least 26 da Vinci robot lawsuits have been filed against Intuitive, with claims of design defect, failure to warn and negligence. Many also say that the company provides inadequate surgical training on its robot, putting patients at increased risk for life-threatening injuries.

Complications reported with da Vinci surgeries include:

  • Internal bleeding caused by torn blood vessels
  • Cut ureters
  • Bowel injuries
  • Vaginal cuff dehiscence
  • Nerve and muscle damage
  • Punctured organs and evisceration
  • Thermal burn injuries

The American Congress of Obstetricians and Gynecologists (ACOG) cautioned against daVinci hysterectomy procedures, based on a lack of evidence showing benefits over traditional surgery. The ACOG stated, “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.”