S3 · 05/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-14774 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
FAILURE ANALYSIS (FA) INVESTIGATIONS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS VISUALLY INSPECTED AND THERE WAS NO PHYSICAL DAMAGE FOUND OR BROKEN PIECES OBSERVED. THE FOREIGN MATERIAL RETURNED DID NOT APPEAR TO BELONG TO THE SILICONE SPRING PAD OF THE B
| 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 |