S3 · 11/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-21922 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT (LOT NUMBER: K14240620-0039) TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, AND PASSED THE RECOGNITION, SEAL AND ENGAGEMENT TESTS ON 3 OF 3 ATTEMPTS. TH
| 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 |