S3 · 05/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-17424 |
| 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. DURING THE PROCEDURE, AN AREA OF ISCHEMIA WAS OBSERVED ON THE LEFT BREAST INFERIOR TO THE NIPPLE AREOLA COMPLEX (NAC). THE AREA WAS COVERED WITH SILVADENE CREAM. THE
| 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 |