S3 · 04/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 04/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-12139 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE INSTRUMENT WAS TRANSFERRED TO A FAILURE ANALYSIS ENGINEER (FAE) AND THE INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. MICROSCOPIC INSPECTION OF THE PIN WHERE THE WASHER GOT DISLODGED SHOWED THAT THE PIN WAS INSUFFICIENTLY SWAGED WHICH LIKELY LED TO THE WASHER GETTING DISL
| 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 |