S3 · 01/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 01/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-00539 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED FROM A SOCIAL MEDIA POST THAT DURING DA VINCI-ASSISTED SURGERIES, THE UNIVERSAL CANNULA SEAL BROKE. IT IS UNCLEAR IF FRAGMENTS FELL INSIDE THE PATIENT AND IF SO, WERE THE FRAGMENTS RETRIEVED. THE SURGEON INDICATED THAT THE OCCURRED TWICE WITHIN THE LAST 2-3 WEEKS.
| 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 |