Intuitive Surgical is recalling one set of its stapler reloads used by its da Vinci robot after incomplete deliveries failed to properly close blood vessels during procedures.
The company reported cases of four serious injuries and one patient death as of late February. The FDA amplified the issue this week, sending out word to clinicians and the public through its early alert program, but has not yet issued a formal recall designation.
Intuitive previously notified surgeons in a letter March 11, saying they should stop using gray reload cartridges for the da Vinci’s 8 mm SureForm 30 curved-tip staplers and switch to alternatives.
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According to the FDA, incomplete staple line formation on blood vessels can end up cutting the tissue and exposing the inside of the blood vessel, causing dangerous bleeding that may require switching from the robot to open surgery.
The curved-tip stapler is employed for the resection and transection of vasculature and tissue as well as for creating anastomoses across surgical specialties, including thoracic, gynecologic, urologic and general procedures.
Intuitive obtained a clearance from the FDA for the 8 mm SureForm curved-tip stapler in late 2021—with reloads being color-coded gray, white or blue based on how deep they enter tissue. Gray and white staples are designed for thin applications such as blood vessels, while blue is for thicker tissue.
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This week also saw Intuitive report a cyberattack, with a phishing incident targeting some of its employees. The company said in a statement that its robotic surgery platforms are secure and separated from its internal business network. Intuitive said the data that were accessed included “some customer business and contact information, as well as Intuitive employee and corporate data.”
The intrusion was minor compared to what Stryker has been weathering. After last week’s attack by a pro-Iran group that remotely wiped and deleted data from many employees’ laptops and smartphones, the company has been working since then to bring its electronic product ordering and replenishment systems back online.
Stryker has said that its sales representatives will work with customers directly to place replenishment orders manually in the interim. In a March 19 update, the company said some surgeries scheduled for the week of March 16 had to be rescheduled due to shipping delays.
