S3 · 03/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 03/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-06860 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE UNIVERSAL SEAL WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE TEARING AT THE DUCKBILL. THE TEARS WERE NOT AXIALLY ALIGNED WITH THE SEAL AND MEASURED FROM 0.232¿ TO 0.160¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. A REVI
| 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 |