S3 · 03/2021 · Asensus Surgical
| Company | Asensus Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 03/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3007593944-2021-00001 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
A DEVICE HISTORY RECORD REVIEW OF EACH OF THE MANIPULATOR ARMS OF THE SENHANCE SYSTEM USED FOR THE CASE HAS BEEN PERFORMED WITH NO ANOMALOUS FINDINGS. THE AUTO-CALIBRATION FILES OF THE MANIPULATOR ARMS FOR THE JOHAN GRASPER WERE LOWER THAN SPECIFICATIONS OUTLINED IN INTERNAL DOCU
| 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 |