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 2955842-2025-38930 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE IESU GENERATOR TO RESOLVE THE ISSUE. THE FSE TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ISI RECEIVED THE IESU GENERATOR TO PERFOR
| 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 |