Safety
Two professors filed a petition asking the FDA to remove the robotic mastectomy use until long-term cancer safety data exist.
A crash, recall, injury or investigation
What the source says
“until long-term oncologic safety and non-inferiority data are established”
What it means
da Vinci SP, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: A surgeon in the operating room controls it; it doesn't operate on its own.
More on da Vinci SP
- Under 510(k) clearance K252675, the FDA cleared da Vinci SP for nipple-sparing mastectomy, a breast cancer operation.
- The FDA cleared da Vinci SP for groin hernia repair, gallbladder removal and appendix removal.
- Intuitive started a Class 2 recall of SP instrument arm drapes (sterile covers), which could come loose from the robot arm.
- The FDA cleared da Vinci SP for colorectal (bowel) surgery.
- The FDA cleared da Vinci SP for more prostate operations, including removal of the whole prostate through the bladder.
- The FDA cleared da Vinci SP for ear, nose and throat surgery done through the mouth.