Intuitive Surgical (NSDQ:ISRG) is recalling 23 lots of staples used with its da Vinci Xi robot-assisted surgery device after internal testing turned up a manufacturing “variation” that could cause an incomplete staple line.
The Sunnyvale, Calif.-based company said the problem with some of its da Vinci Xi SureForm 60 Black and Green Reloads has a low likelihood of occurring. The variation could result in the reloads failing to deploy three adjacent staples, causing a “minor delay” to reinforce the staple line, the company said.
The risk depends on the type of procedure involved, Intuitive said.
“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,” according to Intuitive’s field safety notice.