FDA Adverse Event
Injury
Summary report: N
ETHICON ENDOSURGERY INC
MDR report key: 810809
·
Received January 26, 2007
Report
- Report Number
- MW1041793
- Event Type
- Injury
- Date Received
- January 26, 2007
- Date of Event
- January 11, 2007
- Report Date
- January 26, 2007
- Manufacturer
- *
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHEN ATTEMPTING TO USE ENDOPATH ETS LINEAR CUTTER WITH RELOAD CARTRIDGE IN PLACE, DEVICE DID NOT "CLICK" WHEN FIRED AND CARTRIDGE FELL INTO ABDOMEN. INCISION HAD TO BE EXTENDED TO REMOVE CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDOSURGERY INC | VASCULAR-THIN-ENDOPATH ETS LINEAR CUTTER AND VASCULAR | GCJ | * | TSW35 | C4FTOC | |
| 2 | ETHICON ENDOSURGERY INC. | VASCULAR-THIN ENDOPATH ETS LINEAR CUTTER AND VASCULAR | GCJ | * | TR35W | C4F78W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Disability |