S3 · 02/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 02/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-10317 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE HARMONIC ACE CURVED SHEARS INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT RETURNED TO INTUITIVE SURGICAL INC. (ISI) FOR INVESTIGATION PURPOSE. THEREFORE THE ROOT CAUSE OF THE REPORTED FAILURE MODE COULD NOT BE DETERMINED FOR THIS ALLEGED ISSUE. A REVIEW OF THE SITE'S COMPLAINT
| 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 |