S3 · 03/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 03/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-06751 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT (MDR) WITH MDR REPORT #MW5165586 STATING: ROBOTIC HARMONIC INSTRUMENT BROKE INSIDE THE PATIENT'S ABDOMEN DURING PROCEDURE. THE PIECE THAT BROKE OFF WAS LOCATED AND REMOVED FROM THE PATIENT. THERE WERE NO NOTED INJURIES.
| 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 |