FDA Adverse Event
Malfunction
Summary report: N
45MM ARTICNG LNR CUTR/6 ROW BL
MDR report key: 1210259
·
Received October 21, 2008
Report
- Report Number
- 3005075853-2008-02488
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 26, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO FIRE AT THE FIRST FIRING. IT WAS ALSO FOUND THAT THE STAPLES COULD NOT BE FORMED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45MM ARTICNG LNR CUTR/6 ROW BL | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |