S3 · 03/2026 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 03/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2026-16034 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF CANNOT VERIFY EXTERNAL EVENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE TIP COVER WAS PLACED ON AN IN-HOUSE GOLDEN MCS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-
| 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 |