FDA Adverse Event
Injury
Summary report: N
ETHICON ENDO-SURGERY INC.
MDR report key: 746981
·
Received November 4, 2005
Report
- Report Number
- MW1037115
- Event Type
- Injury
- Date Received
- November 4, 2005
- Date of Event
- November 3, 2005
- Report Date
- November 4, 2005
- Manufacturer
- J & J
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SURGEON STATED THAT THE CLIP APPLIER MISFIRED SEVERAL TIMES DURING PROCEDURE. NO PATIENT HARM OR ADVERSE EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY INC. | LIGACLIP HEMOCLIP | GDO | J & J | MCL20 | Y45J02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Disability |