FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1112604
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01104
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 11, 2008
- Report Date
- August 6, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DID NOT REOPEN TO APPLY SECOND CLIP DURING CRITICAL MOMENT OF CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC | NA | E4KM4V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |