S3 · 01/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 01/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-21970 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING AND THE INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE JAW COVER WAS REMOVED, AND IT WAS NOTED THAT THE END OF THE PIVOT PIN WHERE THE WASHER DISLODGED FROM WAS IMPROPERLY SWAGED, CAUSING THE WASHER TO DISLODGE DURING PROCEDURE.
| 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 |