S3 · 02/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-01627 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ADVANCED FAILURE ANALYSIS WAS PERFORMED, AND THE SEAL WAS DISASSEMBLED TO BETTER EXAMINE THE SEPTUM. THE EXAMINATION FOUND THE PRESENCE OF DAMAGE AND A DETACHED FRAGMENT WERE CONFIRMED HOWEVER THE TORN COMPONENT WAS FOUND TO BE THE SEPTUM INSTEAD OF THE DUCKBILL. THE SEAL WAS FOU
| 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 |