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 2955842-2025-48862 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED FIELDS: D9, H2, H3, H6, AND H11. THE ERBE GENERATOR WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERROR WAS ABLE TO BE CONFIRMED. THE EMBEDDED SERIALIZER FOR MASTER (ESM) UNIT WAS RETURNED FOR FAILURE ANALYSIS. UPON VISUAL INSPECTION NO ISSUES WERE FOUND. THE UNIT W
| 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 |