MAUDE manufacturer profile
AOMORI OLYMPUS CO., LTD. · PKL
MAUDE profile for Hemostatic Metal Clip For The Gi Tract
Key facts
| Manufacturer | AOMORI OLYMPUS CO., LTD. |
|---|---|
| Manufacturer group | AOMORI OLYMPUS CO., LTD. |
| Product code | PKL |
| Product code name | Hemostatic Metal Clip For The Gi Tract |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Hemorrhage/Blood Loss/Bleeding, Adverse Event Without Identified Device or Use Problem, Separation Failure, Failure to Fire, Peeled/Delaminated, Difficult to Open or Close 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