S3 · 07/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-27558 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ADDITIONAL INFORMATION: THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE HARMONIC ACE INSTRUMENT. NO RESISTANCE WAS FELT UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO DAMAGE WAS NOTED TO THE CANNULA. THE FRAGMENT(S) WERE RETRIEVED WHICH WAS CONFIRMED B
| 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 |