S3 · 10/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 10/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-19101 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) RECEIVED (2) MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORIES INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. ON THE FIRST PRODUCT THAT WAS TESTED, FAILURE ANALYSIS (FA) DID NOT REPLICATE OR CONFIRM THE REPORTED ISSUE. THE MCS
| 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 |