S3 · 01/2023 · Asensus Surgical
| Company | Asensus Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 01/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3007593944-2023-00001 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE SURGEON AND THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOT RELATED TO THE USE OF THE SENHANCE SYSTEM USED IN THE FIRST PROCEDURE PERFORMED BUT RATHER INDUCED BY ELECTROCAUTERY. THE ONLY ENERGY POWERED ASENSUS SURGICAL DEVICE USED WAS A MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310
| 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 |