As Robotic Surgical Device Lawsuits Rise, da Vinci Recall Aims to Correct Instrument Arm Flaw | Karl Truman Law Office

February 17, 2014

Intuitive Surgical, which faces a growing number of lawsuits stemming from severe medical complications associated with its da Vinci Surgical System, recently announced a recall to fix or replace defective instrument arms on select models of its surgical robot devices.

da Vinci robot-assisted surgery systems are used in hospitals and surgical centers in the greater Louisville area, throughout Kentucky and Indiana, and nationwide. The recent recall was initiated to correct flaws with the surgical system’s Patient Side Manipulators (PSMs) on da Vinci S, Si and Si-e models; the PSMs are often referred to as instrument arms, and they hold and drive the so-called EndoWrist controls.

In its recall statement, Intuitive Surgical says excess friction within the PSMs of affected models “could interrupt smooth instrument motion.” According to Intuitive Surgical, this interruption may be felt as resistance by the practicing surgeon. If the surgeon “pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position.”

The U.S. Food and Drug Administration (FDA) classified the matter as a Class II recall, which indicates the flaw could lead to temporary or medically reversible adverse effects.

Intuitive Surgical already faces an increasing number of lawsuits related to the da Vinci Surgical System. Severe, and potentially fatal, complications linked to these robot-assisted surgical devices include:

• Internal bleeding
• Internal burns
• Internal tissue tearing
• Organ damage
• Fistulas, or abnormal ducts between organs
• Hematomas, or blood clots that form in tissue or organs as a result of broken blood vessels
• Sepsis, a life-threatening whole-body inflammation caused by infection

da Vinci Surgical Systems have been used in a number of common surgeries including hysterectomies, prostate surgeries, esophageal surgeries and other procedures.