S3 · 11/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-45816 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: APPROXIMATELY ONE MONTH AFTER THE INDEX PROCEDURE, THE LEFT TISSUE EXPANDER WAS REPORTED TO BE DEFLATED. THERE WAS NO CHANGE IN MANAGEMENT EXCEPT THAT THE TISSUE EXPANDER WAS NO LONGER EXPANDED. A SECOND STAGE RECONSTRUCTIO
| Sev | Date | Company | Event |
|---|---|---|---|
| S2 | 2015-06-30 | Hocoma | Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training |