S3 · 02/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-00925 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CURVED BLADE BROKEN AT THE TIP OF THE BLADE. A PIECE APPROXIMATELY 0.084" X 0.680" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS R
| 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 |