S3 · 11/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-20978 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SEAL ACCESSORY WAS ANALYZED AND FOUND TO HAVE TEARS ON THE RUBBER INSIDE THE SEAL MEASURING APPROXIMATE 0.109"X 0.085" IN LENGTH. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYS
| 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 |