S3 · 09/2023 · Asensus Surgical
| Company | Asensus Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 09/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3007593944-2023-00004 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE COMPLAINANT, (B)(6), REPORTED THAT ON DAY 6, THERE WAS AN ANASTOMOTIC LEAKAGE DETECTED, THEN CLINICALLY AND DIGITALLY CONFIRMED. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G 3X DAILY) AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERE
| 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 |