Robots Recall: Da Vinci Warns Customers Arms Can Stall
Imprecise surgical cuts can result.
Published: December 6, 2013
Intuitive Surgical is warning customers that its da Vinci robots can momentarily stall during procedures, potentially causing imprecise surgical cuts.
The FDA has issued a Class II recall of the robots, meaning it believes they could cause "temporary or medically reversible" health problems, with a remote possibility of more serious problems. Intuitive began telling customers in November to inform surgeons and other staff and to schedule inspections for repair or replacement.
The company says surgeons might feel resistance and that if they continue to push, the devices can stall before suddenly catching up, resulting in imprecise cuts. Intuitive says 1 imprecise cut and 2 cases of perceived resistance have been reported in roughly 55,000 procedures performed. It says no patient complications have been reported.
Nearly 70% of the inspections are complete, a company spokesperson tells the Wall Street Journal, and only a "minimal" number have needed adjustments.
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