FDA Adverse Event
Other
Summary report: N
EUS ECHO-25
MDR report key: 2400942
·
Received December 30, 2011
Report
- Report Number
- MW5023692
- Event Type
- Other
- Date Received
- December 30, 2011
- Date of Event
- December 19, 2011
- Report Date
- December 30, 2011
- Manufacturer
- COOK
- Product Code
- FCG
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING EUS WITH FNA ECHO-25, WHEN RN AND PATHOLOGIST WERE ASPIRATING THE SPECIMEN ONTO THE MICROSCOPE SLIDE, THE NEEDLE WOULD NOT ADVANCE. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EUS ECHO-25 | NONE | FCG | COOK | W2680621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |