S3 · 04/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 04/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-10847 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY THE CUSTOMER HAD ISSUES WITH THE FRAGMENT COMING OFF THE SYNCHROSEAL INSTRUMENT. CUSTOMER RETRIEVED FRAGMENT. INTUITIVE SURGICAL INC. (ISI) CONFIRMED THAT THE FRAGMENT CAME OFF THE DEVICE INTO THE PATIENT DURING P
| 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 |