MAUDE manufacturer profile
INTUITIVE SURGICAL, INC · GCJ
MAUDE profile for Laparoscope, General & Plastic Surgery
Key facts
| Manufacturer | INTUITIVE SURGICAL, INC |
|---|---|
| Manufacturer group | INTUITIVE SURGICAL, INC |
| Product code | GCJ |
| Product code name | Laparoscope, General & Plastic Surgery |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Image Orientation Incorrect, Unintended System Motion, Detachment of Device or Device Component, Insufficient Information, Break, Foreign Body In Patient, Material Fragmentation Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1