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 3007593944-2023-00009 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE COMPLAINANT, DR. (B)(6) REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEA
| 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 |