S3 · 09/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 09/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-19862 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE ENDOSCOPE CONTROLLER (EC), REPLACED BY THE FIELD SERVICE ENGINEER (FSE), WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND WENT THROUGH VIDEO TEST, 10 POWER C
| 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 |