S3 · 06/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-16176 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY AND FAILURE ANALYSIS TESTING WAS COMPLETED. THE PRODUCT WAS FOUND TO HAVE TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT. THE TEAR IS AXIALLY ALIGNED WITH THE TIP COVER AND MEASURES APPROXIMATELY 0.055¿ IN LEN
| 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 |