FDA Adverse Event
Malfunction
Summary report: N
1 ENDOPATH
MDR report key: 1020006
·
Received March 14, 2008
Report
- Report Number
- 1020006
- Event Type
- Malfunction
- Date Received
- March 14, 2008
- Date of Event
- February 19, 2008
- Report Date
- March 14, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- OCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE STAPLE CARTRIDGE FELL OUT OF THE STAPLER WHEN INSERTING THE STAPLER INTO THE PATIENT'S CHEST. NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1 ENDOPATH | STAPLER, SURGICAL | OCW | ETHICON ENDO-SURGERY, INC. | * | D4JCOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |