Recent da Vinci Recall Addresses Faulty Instrument Arms as Robotic Surgical Device Lawsuits Mount

Already facing mounting lawsuits related to its da Vinci Surgical System, Intuitive Surgical recently initiated a voluntary recall to repair or replace faulty instrument arms on certain robot-assisted surgery devices.

Our Philadelphia-based consumer class action attorneys at Golomb Legal, P.C. are dedicated to helping victims of dangerous medical devices pursue the financial peace of mind they need to move forward with their lives. If you or a loved one suffered injury that may have been related to the use of a da Vinci Surgical System, please call (215) 278-4449 for your free case evaluation; our accomplished lawyers welcome clients from Pennsylvania, New Jersey and nationwide.

The recent da Vinci recall was intended to address potential problems with the so-called Patient Side Manipulators (PSMs) on S, Si and Si-e model da Vinci Surgical Systems. PSMs are the instrument arms of the robotic devices.

According to Intuitive Surgical's notice on the matter, excessive friction within the instrument arms of certain affected models "could interrupt smooth instrument motion." This interruption is felt as resistance by the conducting surgeon; if the surgeon pushes through this resistance, Intuitive says "the instrument could stall momentarily and then suddenly catch-up to the correct position."

In its own notice, the U.S. Food and Drug Administration (FDA) categorized the issue as a Class II recall, which means the PSM defect could result in "temporary or medically reversible" complications if not corrected. As for the da Vinci Surgical System itself, an increasing number of lawsuits allege that use of the robotic devices in hysterectomies, prostate surgeries and other surgical treatments has led to severe-and sometimes fatal-complications.

Adverse effects associated with da Vinci devices include:

  • Internal burns
  • Internal tissue tears and punctured organs
  • Hematomas (blood clots that form within tissue or organs as a result of broken blood vessels)
  • Fistulas (abnormal connections between organs)
  • Sepsis (a potentially deadly whole-body inflammation caused by infection)