MAUDE manufacturer profile
COOK ENDOSCOPY · PTK
MAUDE profile for Pediatric Esophageal Atresia Anastomosis Device
Key facts
| Manufacturer | COOK ENDOSCOPY |
|---|---|
| Manufacturer group | COOK ENDOSCOPY |
| Product code | PTK |
| Product code name | Pediatric Esophageal Atresia Anastomosis Device |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure to Anastomose, Failure to Advance, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Patient-Device Incompatibility, Perforation of Esophagus, Stenosis of the esophagus, No Consequences Or Impact To Patient 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