S3 · 01/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 01/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-00196 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT ARM DRAPE AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT ARM DRAPE WAS ANALYZED AND FOUND TO HAVE FAILED THE SPIN TEST. THE DRAPE WAS INSTALLED ON AN IN-HOUSE SYSTEM AND COMPLETED THE SETUP. THE SPIN TEST WAS PERFO
| 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 |