FDA Adverse Event
Malfunction
Summary report: N
PROX ACCESS 55MM ART STAP REG
MDR report key: 1823619
·
Received August 16, 2007
Report
- Report Number
- 1527736-2007-05427
- Event Type
- Malfunction
- Date Received
- August 16, 2007
- Date of Event
- July 4, 2007
- Report Date
- August 3, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A COLON PROCEDURE THE DEVICE DELIVERED AN INCOMPLETE STAPLE LINE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROX ACCESS 55MM ART STAP REG | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | C4FX1W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |