S3 · 07/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-17058 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CANNULA SEAL WAS ANALYZED AND FOUND TO HAVE BROKEN AT THE LUER FITTING. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT STILL ATTACHED TO THE INSUFFLATION TUBING. THE SECOND CANNULA SEAL
| 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 |