S3 · 06/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-16582 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO STATEMENT OR INDICATION OF ANY ISSUES WITH THE DAVINCI ROBOTIC SYSTEMS. SECTION A2 PATIENT AGE: AGE RANGE FOR THE SP SYSTEM POPULATION: (Y), X +/- SD: 69.0 +/- 7.
| 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 |