S3 · 12/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 12/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2023-21618 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. THE CUSTOMER USED THE SAME INSTRUMENT TO COMPLETE THE PROCEDURE. FRAGMENTS WERE REPORTED TO FALL INSIDE THE PATIENT AND WERE RETRIEVED FROM THE BODY DURING T
| 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 |