S3 · 02/2026 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2026-04348 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AN INTUITIVE SURGICAL, INC. (ISI) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) #4. THE FSE THEN TEST DROVE THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READ FOR USE. ISI RECEIVED THE PSM ASSOCIAT
| 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 |