S3 · 11/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-21674 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE THE BLADE BROKEN AT THE MIDPOINT. A PIECE APPROXIMATELY 0.084" X 0.205" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS
| 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 |