S3 · 11/2021 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 11/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2021-11561 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE. THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED FOR EVALUA
| 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 |