S3 · 12/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-47214 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. NO SITE VISIT WAS CONDUCTED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND IDENTIFIED AN INSTRUMENT SENSOR MISSING ERROR ON PATIENT SIDE MANIPULATOR (PSM) 1 PROMPTING A CONNECTION ISSUE. THE SYSTEM WAS WORKING PROP
| 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 |