S3 · 08/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-33097 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED: G3, G6, H2, H11, ANNEX E, ANNEX F, ANNEX G, ANNEX D. AN ADDITIONAL FAILURE ANALYSIS WAS PERFORMED ON THE ENDOSCOPE. THE FOCUS OF ENDOSCOPE WAS TESTED ON A SYSTEM OR EQUIVALENT AND FOUND TO FAIL THE FOCUS TEST. THE ENDOSCOPE WAS FOUND WITH FLICKERING/ROLLING IMAGE. ADDITI
| 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 |