S3 · 05/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-13052 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ADDITIONAL INFORMATION WAS OBTAINED AS THE FOLLOWING: THE PATIENT WAS DIAGNOSED WITH ACUTE HYPOXIC RESPIRATORY FAILURE AND ACUTE HYPERCARBIA RESPIRATORY FAILURE AFTER TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS PLACED ON AN AEROSOLIZED MASK AT 15L 40% FIO2 AND STARTED
| 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 |