S3 · 07/2022 · Intuitive Surgical
| Company | Intuitive Surgical |
| Category | medical robotics |
| Type | injury |
| Date | 07/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2955842-2022-12936 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE THERMAL DAMAGE SEEN ON THE MCS TIP COVER ACCESSORY IS TYPICALLY DUE TO MISHANDLING/MISUSE. THERE WAS NO SIGNS OF THERMAL DAMAGE AT THE DISTAL END OF THE MCS INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INF
| 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 |