S3 · 05/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-14528 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INTO THE PATIENT. THIS HAPPENED TWICE IN THE SAME PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUIT
| 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 |