MAUDE manufacturer profile
KARL STORZ ENDOSCOPY-AMERICA. INC · GCJ
MAUDE profile for Laparoscope, General & Plastic Surgery
Key facts
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA. INC |
|---|---|
| Manufacturer group | KARL STORZ ENDOSCOPY-AMERICA. INC |
| Product code | GCJ |
| Product code name | Laparoscope, General & Plastic Surgery |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, Foreign Body In Patient, Detachment Of Device Component, Device Fell, Electrical /Electronic Property Problem 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