S3 · 08/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-34594 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED ADVERSE EVENTS OR DA VINCI DEVICE MALFUNCTIONS. IT WAS REPORTED THAT RIGHT BREAST LATERAL FIRMNESS DEVELOPED W
| 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 |