S3 · 04/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 04/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-13692 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED SYSTEM COMPONENT(S) TO RESOLVE THE REPORTED ISSUE. THE MASTER TOOL MANIPULATOR (MTM) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE MTM WAS ANALYZED AND FOUND TO HAVE AN ERROR IN THE L
| 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 |