MAUDE manufacturer profile
OLYMPUS WINTER & IBE GMBH · GCJ
MAUDE profile for Laparoscope, General & Plastic Surgery
Key facts
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
|---|---|
| Manufacturer group | OLYMPUS WINTER & IBE GMBH |
| Product code | GCJ |
| Product code name | Laparoscope, General & Plastic Surgery |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Detachment of Device or Device Component, Sparking, Crack, No Known Impact Or Consequence To Patient, Mechanical Problem, 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