S3 · 11/2021 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2021-11495 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. ISI REQUESTED FOR RETURN OF THE SYNCHROSEAL INSTRUMENT USED TO SEAL THE SHORT GASTRIC ARTERY, PART NUMBER: 480440-05, LN: L90210726-0118 FOR FAILURE ANALYSI
| 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 |