S3 · 09/2020 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 09/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2020-10955 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ALLEGED OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE SITE HAS DISCARDED THE SYNCHROSEAL INSTRUMENT. THEREFORE, THE INSTRUMENT IS NOT AVAILABLE FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL B
| 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 |