FDA Adverse Event
Other
Summary report: N
EPIX UNIVERSAL
MDR report key: 4360710
·
Received December 16, 2014
Report
- Report Number
- MW5039733
- Event Type
- Other
- Date Received
- December 16, 2014
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GDO
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE 5MM END STAPLER FAILED TO CLOSE CLIPS AROUND CYSTIC DUCT AND ARTERY ON LAPAROSCOPE GALLBLADDER PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823623 | EPIX UNIVERSAL | CLIP APPLIER | GDO | APPLIED MEDICAL | 1226145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |