FDA Adverse Event
Malfunction
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 714851
·
Received November 18, 2005
Report
- Report Number
- 1527736-2005-05616
- Event Type
- Malfunction
- Date Received
- November 18, 2005
- Date of Event
- November 5, 2005
- Report Date
- November 11, 2005
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN RAB PROCEDURE, THE DEVICE DELIVERED AN INCOMPLETE STAPE LINE. IT WAS NOT MENTIONED HOW THE CASE WAS COMPLETED. THERE WAS NOT PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | CURVED CUTTER STAPLER | GDW | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |