S3 · 06/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-12486 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION IS MOST LIKELY DUE TO USE ERROR AS STATED BY THE SURGEON. THE SPECIFIC INSTRUMENT(S) INVOLVED WITH THE EVENT, IS UNKNOWN. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DE
| 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 |