FDA Adverse Event
Malfunction
Summary report: N
COVIDIEN
MDR report key: 4342830
·
Received December 11, 2014
Report
- Report Number
- MW5039640
- Event Type
- Malfunction
- Date Received
- December 11, 2014
- Date of Event
- December 1, 2014
- Report Date
- December 3, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FIVE MM ENDOCLIP DEVICE BECAME JAMMED DURING PROCEDURE AND WOULD NOT FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803936 | COVIDIEN | ENDO CLIP III 5 MM | GDO | COVIDIEN | N4K1039MX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |