MAUDE manufacturer profile
SHIRAKAWA OLYMPUS CO., LTD. · ODG
MAUDE profile for Endoscopic Ultrasound System, Gastroenterology-Urology
Key facts
| Manufacturer | SHIRAKAWA OLYMPUS CO., LTD. |
|---|---|
| Manufacturer group | SHIRAKAWA OLYMPUS CO., LTD. |
| Product code | ODG |
| Product code name | Endoscopic Ultrasound System, Gastroenterology-Urology |
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, Failure to Clean Adequately, Peeled/Delaminated, Material Split, Cut or Torn, Material Separation, Microbial Contamination of Device, Detachment of Device or Device Component, Crack 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