S3 · 07/2026 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2026-32610 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS. EVALUATION OF THE INSTRUMENT FOUND ONE BLADE BROKEN AT THE BASE, WITH A SECTION MEASURING APPROXIMATELY 0.476" X 0.084" IN SIZE MISSING. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT
| 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 |