www.fdanews.com/articles/191908-surgical-devicemaker-recalls-staples-over-manufacturing-violation
Surgical Devicemaker Recalls Staples over Manufacturing Violation
July 8, 2019
Sunnyvale, California-based device manufacturer Intuitive issued a recall for 23 lots of staples used with its da Vinci Xi, a robot system that enhances surgical performance.
The company said a rare “manufacturing variation” in its da Vinci Xi SureForm 60 Stapler Reload product causes three staples not to deploy, resulting in an incomplete stapling line.
“In rare situations there is a theoretical possibility that this could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention,” the company said.