S3 · 07/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-31856 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A ROBOTIC HELLER MYOTOMY, A FRAGMENT DETACHED FROM THE CANNULA SEAL AND FELL INSIDE THE PATIENT. THERE WAS UNCERTAINTY ABOUT ITS ORIGIN, WHETHER IT WAS FROM THE PRODUCT ITSELF OR ALREADY PRESENT IN THE TROCAR DUE TO PACKAGING OR MANUFACTURING. THE FRAG
| 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 |