S3 · 05/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-18856 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
A SITE VISIT WAS MADE BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) AND THE SYSTEM WAS TESTED, BUT NO ISSUE WAS FOUND. THE SYSTEM WAS TESTED AND VERIFIED FOR USE. THE MONOPOLAR CURVED SCISSORS (MCS) USED WAS RETURNED FOR FAILURE ANALYSIS (FA). THE INSTRUMENT
| 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 |