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 2955842-2025-46212 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED SECTIONS: H2 AND H11. ADDITIONAL INFORMATION: ADDITIONAL REVIEW OF THE CUSTOMER PROVIDED IMAGES SHOWS THAT IN THE FIRST IMAGE, THE SYNCHROSEAL INSTRUMENT IS SHOWN GRASPING TISSUE. IN THE SECOND IMAGE, TISSUE IS VISIBLE WITH CHARRING THAT MATCHES THE SHAPE OF THE INSTRUMEN
| 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 |