S3 · 05/2026 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2026-26312 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE HARMONIC ACE INSTRUMENT WILL NOT BE RETURNED. IMAGES PROVIDED BY THE CUSTOMER WERE REVIEWED. IN TWO IMAGES , THE TEFLON PAD OF A HARMONIC INSTRUMENT APPEARS TO HAVE SOME MISSING PIECES. IN ANOTHER IMAGE, A BROKEN BLADE IS SEEN BUT NO MISSING PIECES ARE OBSERVED.
| 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 |