S3 · 08/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-17630 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE SYNCHROSEAL INSTRUMENT WAS TRANSFERRED TO ENGINEERING AND EVALUATED BY THE FAILURE ANALYSIS ENGINEERING (FAE) TEAM. THE INITIAL FAILURE ANALYSIS (FA) EVALUATION WAS CONFIRMED. MICROSCOPIC INVESTIGATION OF THE PIVOT PIN REVEALED AN IMPROPERLY SWAGED END, WHICH IS KNOWN TO BE R
| 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 |