S3 · 05/2021 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2021-10587 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION AS THE SITE DISCARDED THE ITEM. THE SITE ALSO INFORMED THAT THE MCS INSTRUMENT IS ALSO NOT AVAILABLE FOR ISI EVALUATION. THEREFORE, FAILURE ANALYSIS OF TH
| 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 |