S3 · 03/2024 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 03/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5152955 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
ROBOTIC MEGA SUTURE CUT NEEDLE DRIVER'S WIRES BROKE WHILE INSIDE PATIENT. SURGEON AWARE. NO VISIBLE SIGNS OF ANY PIECES LEFT INSIDE PATIENT. INSTRUMENT REMOVED FROM SERVICE AND GIVEN TO RISK MANAGER.
| 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 |