FDA Adverse Event
Summary report: N
LIGACLIP
MDR report key: 2092143
·
Received May 4, 2011
Report
- Report Number
- 2092143
- Date Received
- May 4, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 2, 2011
- Manufacturer
- ETHICON ENDO
- Product Code
- FZP
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LIGACLIP OPEN FOR A GASTRIC BYPASS. THE SCRUB NURSE CHECKED THE CLIP AND NOTICED REFILL CLIP WAS SLOW TO RELOAD. LIGACLIP REMOVED FROM FIELD AND REPLACED WITH A NEW LIGACLIP.======================MANUFACTURER RESPONSE FOR LIGACLIP, LIGACLIP (PER SITE REPORTER)======================NO RESPONSE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP | CLIP APPLIER | FZP | ETHICON ENDO | ER420 | #F4PJ2U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |