S3 · 07/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-16745 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE SYNCHROSEAL INSTRUMENT WAS EVALUATED BY THE ADVANCED FAILURE ANALYSIS TEAM AND THE INITIAL FINDINGS WERE CONFIRMED. THE SYNCHROSEAL INSTRUMENT HAD ONE OF THE PIVOT PIN WASHERS MISSING. AFTER REMOVING THE JAW COVER, IT WAS NOTED THAT THE SWAGED END OF THE PIVOT PIN LOOKED NORM
| 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 |