S3 · 06/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-27515 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) INVESTIGATION WAS PERFORMED, AND THE REPORTED EVENT WAS NOT REPLICATED. THE FSE COULD NOT REPRODUCE ANY ERRORS OR MALFUNCTIONS DESCRIBED BY THE CUSTOMER. NO ISSUES WERE FOUND. HOWEVER, THE FSE REPLACED THE GENERATOR.
| 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 |