Intuitive Surgical Issues ‘Urgent’ Recall for da Vinci Surgical Robot

Intuitive Surgical warns that internal issues with its da Vinci surgical robot may cause the robot’s arms to seize up and stall during surgery, potentially leading to patient injury or death.

Intuitive Surgical Issues Recall for da Vinci Robotic Arms

The da Vinci Surgical System is a surgeon controlled robot used in keyhole surgeries that require precession and a steady hand.  Unfortunately, as the number of surgeons using the surgical robot has increased, so has the number of adverse events reported to the FDA.

According to the Daily Mail, Intuitive Surgical has issued an ‘urgent medical device recall’ for the robotic arms of its da Vinci Surgical System after finding that friction can cause the arms of the 1.5 million-dollar medical device to stall or seize up in the middle of surgery.

Recent event reports received by the FDA include an incident in which the hand of the surgical robot would not let go of tissue grasped during surgery and an incident in which a woman was hit in the face by one of the robotic arms while on an operating table.

The FDA estimates that the problem could affect 1,386 robotic arms across the world.

FDA Investigates da Vinci Surgical System

  • A recent increase in the number of injuries and death linked to the da Vinci Surgical System has led an FDA investigation.
  • According to a report issued by the FDA last month, the number of malfunctions, injuries and deaths linked to the surgical robot has double since 2012.
  • The report came shortly after one of Intuitive Surgical’s insurers filed a lawsuit claiming the company concealed legal claims of the device.
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