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 2955842-2025-01619 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ON 04-APR-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: INITIAL FAILURE ANALYSIS WAS PARTIALLY CONFIRMED, IN THAT THE DAMAGE TO THE SEAL WAS CONFIRMED. HOWEVER, THE DAMAGE WAS FOUND TO BE LOCATED ON THE SEAL'S SEPTUM. THE SEAL WAS DISASSEMBLED DURING ADVANCED FAILURE A
| 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 |