S3 · 06/2026 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2026-26861 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RETURNED TO INTUITIVE FOR FAILURE ANALYSIS. REVIEW OF PROVIDED IMAGES SHOW THAT IT LOOKS LIKE THE HARMONIC ACE CURVED BLADE HAS BROKEN AND FALLEN INTO THE PATIENT.
| 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 |