S3 · 12/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-21379 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ON (B)(6) 2024, THE SURGEON PROVIDED ADDITIONAL INFORMATION: REFLECTING ON THE CASE, THE SURGEON WAS CERTAIN THE DAMAGE OCCURRED AS THEY WERE ON THE LEARNING CURVE AND USED MONOPOLAR TOO CLOSE TO THE SYNCHROSEAL AND WAS CERTAIN THEY CAUSED THE ISSUE AND NOT AN INSTRUMENT DEFECT.
| 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 |