S3 · 12/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2024-22969 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER WEDGE RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RESPONDING SATISFACTORILY TO COMMANDS. IN ADDITION, THE TIP OF THE INSTRUMENT BROKE, REQUIRING REMOVAL FROM THE PATIENT'S CAVITY. IT IS UNCLEAR IF A FRAGMENT FROM
| 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 |