FDA Adverse Event
Summary report: N
EPIX UNIVERSAL CLIP APPLIER
MDR report key: 2832054
·
Received October 26, 2012
Report
- Report Number
- 2027111-2012-00323
- Date Received
- October 26, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 26, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAP CHOLE - "DURING THE CASE, THE JAWS OF THE CLIP APPLIER FELL OUT ALONG WITH ALL OF THE CLIPS IN THE CLIP APPLIER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIX UNIVERSAL CLIP APPLIER | NONE | FZP | APPLIED MEDICAL | CA500 | 1165894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |