S3 · 06/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-23463 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED FOR THE SYNCHROSEAL INSTRUMENT, BUT IT HAS NOT BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS INVESTIGATIONS. THE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP REGARDING THE E-100 GENERATOR AND THE SITE CONFIRMED N
| 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 |