Intuitive Surgical warns on embolism risk with da Vinci Xi in heart procedures

Intuitive Surgical (NSDQ:ISRG) today warned of the risk that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.

Sunnyvale, Calif.-based Intuitive said it hasn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals.

“The particulate has the potential to be introduced into the cannula lumen when insufflation is connected. Although there have been no injuries identified related to this issue, we are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart,” the company said. “During abdomino-pelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (HDPE) particulate, its small size and the benign particulate geometry.”

The particulates are less than ⅛ in. long and do not have sharp edges, Intuitive said, noting that HDPE has a nearly 80-year history of use as an implant material. It has no iron content and is therefore safe for MRI scans, the company said.

Intuitive said customers should not use the da Vinci Xi 5mm-8mm universal seal or the 12mm & stapler universal seal during intra-cardiac procedures. An angiocatheter or Veress needle could be used instead, the company said.

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