S3 · 02/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-01012 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. THE UNIVERSAL SEAL WAS ANALYZED AND FOUND TO HAVE TEARING AT THE DUCKBILL. THE TEARS WERE NOT AXIALLY ALIGNED WITH THE SEAL AND MEASURED FROM 0.170¿ TO 0.214¿ IN LENGTH. THERE WERE NO SIGN
| 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 |