S3 · 08/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 08/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-17768 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IN RESPONSE TO AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SURVEY ON XI / X MONOPOLAR INSTRUMENTS, A CUSTOMER RECALLED AN EVENT REGARDING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A MALFUNCTION AND / OR BREAKAGE OF AN UNSPECIFIED DA VINCI MON
| 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 |