S3 · 12/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-47904 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENERGY SHIELD MONITOR (ESM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ESM WAS ANALYZED AND FOUND TO HAVE NO FUNCTIONAL ISSUES WHEN INSTALLED ON AN IN-HOUSE
| 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 |