FDA Adverse Event
Summary report: N
LIGAMAX ENDOSCOPIC CLIP APPLIER
MDR report key: 1883453
·
Received October 18, 2010
Report
- Report Number
- 1883453
- Date Received
- October 18, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 18, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STAFF REPORTED A FAILURE OF THE DEVICE TO FIRE; STATED THE PISTOL GRIP HANDLE DID NOT WORK.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DID NOT RESULT IN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX ENDOSCOPIC CLIP APPLIER | CLIP, IMPLANTABLE | FZP | ETHICON ENDO-SURGERY, LLC | EL5ML | G4T71A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 MO |