S3 · 02/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-11239 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETUR
| 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 |