S3 · 12/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-23342 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ON 20-DEC-2024, ADDITIONAL INFORMATION WAS OBTAINED: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGEON WAS DISSECTING WHEN THE FRAGMENT FELL INTO THE PATIENT. THE SURGEON BELIEVES THAT THE CAUSE OF THE INSTRUMENT BREAKAGE IS DUE TO INHERENT REASONS. I
| 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 |