S3 · 05/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-20594 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. THERE WAS NO DAMAGE OBSERVED DURING VISUAL INSPECTION. THE INSUFFLATION PORT WAS NOT BROKEN AND THE STOPCOCK WAS NOT LOOSE. NO PRODUCT ISSUE WAS IDENTIFIED.
| 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 |