S3 · 09/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 09/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-35985 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
UPDATE TO B5: ADDITIONAL INFORMATION WAS OBTAINED. THE ISSUE WAS IDENTIFIED DURING A DONOR HEPATECTOMY PROCEDURE AT 09:35 AM ON (B)(6) 2025. DURING THE PROCEDURE, WHILE DISSECTING, A DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON WAS UNSURE OF WHAT CAUSED THE FRAGMENT TO DE
| 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 |