S3 · 09/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 09/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-38925 |
| 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 CANNULA MOUNT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE SYSTEM LOGS, CANNULA SENSOR ERRORS WERE SEEN, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING
| 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 |