S3 · 08/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-13650 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CAN BE ATTRIBUTED TO THE PROCEDURE AND UNDERLYING DISEASE AND IS UNRELATED TO THE STUDY DEVICE, ACCORDING TO THE STUDY INVESTIGATOR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF DA VINCI SYSTEM, INSTRUMENT,
| 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 |