S3 · 10/2020 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 10/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2020-11115 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) REQUESTED FOR THE SYNCHROSEAL INSTRUMENT TO BE RETURNED FOR EVALUATION, BUT THE CUSTOMER DISCARDED THE SYNCHROSEAL INSTRUMENT AND, THEREFORE, WILL NOT BE RETURNING THE SYNCHROSEAL INSTRUMENT FOR ISI'S EVALUATION. IMAGE/VIDEO REVIEW: AN IMAGE OF THE
| 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 |