S3 · 08/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-13508 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
INTUITIVE SURGICAL, INC. (ISI) IS NOT EXPECTING ANY PRODUCT TO BE RETURNED AS PART OF THIS COMPLAINT, AS THERE WAS NO ALLEGATION OF A PRODUCT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 20
| 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 |