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 2955842-2025-30375 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS OBSERVED. WHEN THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION OF TISSUE. THE SURGEON BELIEVED THAT THE CAUSE OF THE INSTRUMENT BREAKAGE WA
| 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 |