S3 · 11/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-19723 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN O
| 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 |