S3 · 12/2021 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2021-11774 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION, SO NO PRODUCT IS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE A
| 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 |