Intuitive Surgical (NSDQ:ISRG) today released a field safety notice it sent to da Vinci customers regarding the use of the da Vinci EndoWrist instruments with a cryoablation probe, warning of issues involving microscopic metallic particulate.
The robotic surgery giant advised customers to not use any da vinci instruments other than the Cardiac Probe Grasper to manipulate cardiac cryoablation probes due to an increased amount of microscopic metallic particulate.
The company said it received 5 reports of post da Vinci mitral valve repair patients who showed artifacts consistent with metallic microemboli in MRIs, but said it has not been confirmed whether the surgery with the robotic system was the source for the artifacts.
Of the 5 reported cases, only 2 patients presented with temporary minor neurological symptoms, Intuitive Surgical said, but could not link the symptoms to the artifacts.
The company said that flushing of the heart prior to closure is “common clinical practice,” and that while the particulate could potentially contribute to microemboli in the brain, it is unlikely that a patient would suffer permanent neurological impairment due to the microemboli from a da Vinci intra-cardiac procedure.
The warning affects Intuitive Surgical’s da Vinci S, SI and XI systems.
The company advised hospitals to distribute the letter it sent to all da Vinci operators at healthcare facilities, and that it will update its user manual to reflect the new warning.