FDA Adverse Event
Summary report: N
EPIX UNIVERSAL CLIP APPLIER
MDR report key: 2851016
·
Received November 16, 2012
Report
- Report Number
- 2027111-2012-00360
- Date Received
- November 16, 2012
- Date of Event
- October 30, 2012
- Report Date
- November 16, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVAL BUT LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Description of Event or Problem · 1
LAP CHOLE: "CLIP JAW NOT OPENING AFTER CLIP FIRED." PT STATUS: "PT IS DOING FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIX UNIVERSAL CLIP APPLIER | NON | FZP | APPLIED MEDICAL | CA500 | 1167845 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |