FDA Adverse Event
Summary report: N
EPIX UNIVERSAL CLIP APPLIER
MDR report key: 2885269
·
Received December 18, 2012
Report
- Report Number
- 2027111-2012-00392
- Date Received
- December 18, 2012
- Date of Event
- December 3, 2012
- Report Date
- December 18, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION FO INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION 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 - "SURGEON CLAIMS THE CLIPS WERE NOT STAYING ON THE VESSELS AND WERE EITHER SLIDING OR PULLING OFF; NO RETENTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIX UNIVERSAL CLIP APPLIER | NONE | FZP | APPLIED MEDICAL | CA500 | 1170637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |