S3 · 06/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-15518 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC AVE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE THE CURVED BLADE BROKEN AT THE TIP. A PIECE APPROXIMATELY 0.387" X * 0.068" WAS FOUND TO BE BROKEN OFF.
| 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 |