S3 · 05/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 05/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-13473 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROID RESECTION SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSERT BROKE OFF AND FELL INSIDE THE PATIENT DURING FIRING. THE FRAGMENT WAS RETRIEVED THROUGH AN ASSISTANT PORT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN ENDOS
| 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 |