FDA Adverse Event
Malfunction
Summary report: N
LIGAMAX 5 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER
MDR report key: 2190789
·
Received July 29, 2011
Report
- Report Number
- MW5021581
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 29, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGEON WAS USING CLIP APPLIER DEVICE AND IT WORKED A FEW TIMES AND THEN STOPPED WORKING. NO HARM OR ADVERSE OUTCOME TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX 5 5 MM ENDOSCOPIC MULTIPLE CLIP APPLIER | MULTIPLE CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, LLC | REF EL5ML | H4412C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |