S3 · 07/2020 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2020-10640 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D4, D10, G4, G7, H2, H3, H6 AND H10. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE (480275-08/M90190818 0197) WAS PERFORMED. THE INSTRUMENT WAS LAST USED ON 06/08/2020 ON SYSTEM SK3104. THIS IS A SINGLE-USE INST
| 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 |