S3 · 06/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-16347 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN INSTRUMENT FRAGMENT FALLING INSIDE THE PATIENT, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTO
| 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 |