S3 · 06/2023 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 06/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5118476 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE GEAR/CABLE MECHANISM OF THE FENESTRATED FORCE BIPOLAR BROKE WHILE GRASPING THE STOMACH. THE INSTRUMENT COULD NOT BE OPENED (WITH HELP OF INTUITIVE SUPPORT - WOULD NOT OPEN W/IRK) SO THE STOMACH WAS FORCIBLY REMOVED WHICH CAUSED A LARGE HOLE IN THE STOMACH. STOMACH REPAIRED IN
| 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 |