FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Surgical Devicemaker Recalls Staples over Manufacturing Violation

July 9, 2019
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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.

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