S3 · 04/2025 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 04/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2025-15514 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE SYNCHROSEAL INSTRUMENT WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A DISLODGED AND MISSING HEAT STAKED PLASTIC THAT CONNECTS THE CUT ELECTRODE WITH THE JAW. THE PLASTIC WAS NOT IN ITS ORIGINAL LOCATION AND WAS MISSING. THE CUT ELECTRODE WAS STILL IN PLACE.
| 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 |