S3 · 08/2020 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2020-10743 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED ISSUE THAT THE INSTRUMENT HAD BROKEN METAL AROUND THE INSTRUMENT¿S WRIST AREA. THE
| 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 |