S3 · 10/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 10/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-20193 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ON (B)(6) 2025 FURTHER FAILURE ANALYSIS INVESTIGATION WAS PERFORMED ON THE SYNCHROSEAL INSTRUMENT. DUE TO THE EXTENT OF THE DAMAGE OBSERVED ON THE JAW COVER, IT IS LIKELY THAT THE JAW COVER (SOFT SILICONE MATERIAL) WAS STRETCHED AND PULLED OVER THE PIVOT PIN WASHER DURING AN INTR
| 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 |