S3 · 05/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-14368 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE HARMONIC ACE INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE REPORTED FAILURE WAS CONFIRMED AND REPLICATED. THE GRIP PIN WAS STILL INTACT AND THROUGH THE GRIP, IN ITS ORIGINAL POSITION. HOWEVER, A PIECE WAS BROKEN OFF OF THE GRIP PIN. THE MISSING
| 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 |